MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2019-09-25 for BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS WITH BALLARD TECHNOLOGY 196-5 109838402 manufactured by Avanos Medical Inc..
| Report Number | 8030647-2019-00090 |
| MDR Report Key | 9115666 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2019-09-25 |
| Date of Report | 2019-11-27 |
| Date Mfgr Received | 2019-11-06 |
| Device Manufacturer Date | 2019-03-22 |
| Date Added to Maude | 2019-09-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT S DE RL DE CV |
| Manufacturer Street | CARRETERA INTERNACIONAL SALIDA NORTE NO. 1053 |
| Manufacturer City | MAGDALENA, CP |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS WITH BALLARD TECHNOLOGY |
| Generic Name | VAP CLOSED SUCTION CATHETERS & ACCESSORIES |
| Product Code | BSY |
| Date Received | 2019-09-25 |
| Returned To Mfg | 2019-09-16 |
| Model Number | 196-5 |
| Catalog Number | 109838402 |
| Lot Number | M19077T504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-25 |