MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2010-10-21 for SPECIFIC PATIENT HOME BAG LCLC102E manufactured by Baxter Healthcare - Sesto Fiorentino.
[1836377]
The customer reported to baxter (b)(4) on (b)(6) 2010 an incident where the syringe code had a hole in it and the piston was broken with the specific patient home bag. This incident occurred before use. There was no patient injury or medical intervention associated with this report. No additional information was available.
Patient Sequence No: 1, Text Type: D, B5
[8914335]
The sample is reported to be available for evaluation. A follow up report will be filed if the sample is returned and evaluated or if any additional information becomes available. This device is manufactured for distribution outside of the united states (us); therefore, it does not contain a us 510k number. However, this mdr is being submitted because it is the same as or similar to a product distributed within the us. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9116511]
(b)(4). The product with the alleged defect is not a baxter product; therefore, baxter does not have reporting responsibility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000001-2010-04400 |
| MDR Report Key | 1879094 |
| Report Source | 01,04,07 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-09-26 |
| Date of Event | 2010-09-26 |
| Date Mfgr Received | 2011-04-11 |
| Date Added to Maude | 2011-07-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE - SESTO FIORENTINO |
| Manufacturer Street | VIA DELL'OSMANNORO 253, SESTO, |
| Manufacturer City | SESTO FIORENTINO 50019 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 50019 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECIFIC PATIENT HOME BAG |
| Generic Name | BAG, RESERVOIR |
| Product Code | BTC |
| Date Received | 2010-10-21 |
| Catalog Number | LCLC102E |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - SESTO FIORENTINO |
| Manufacturer Address | VIA DELL'OSMANNORO 253, SESTO, SESTO FIORENTINO IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-21 |