MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-14 for BARD * 0005290 manufactured by Davol C R Bard Inc..
[87216]
Pt delivered infant by cesarean section. Immediately upon delivery, pediatrician tried to suction copious amts of fluid from mouth & nose of infant. Bulb defective, split at seam. Unable to suction. Babe to warmer & suctioned with de lee. Babe under o2/hood following for tachypnea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 144426 |
| MDR Report Key | 144426 |
| Date Received | 1998-01-14 |
| Date of Report | 1998-01-05 |
| Date of Event | 1997-12-31 |
| Date Facility Aware | 1998-01-05 |
| Report Date | 1998-01-05 |
| Date Added to Maude | 1998-01-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD |
| Generic Name | BULB SYRINGE |
| Product Code | KCP |
| Date Received | 1998-01-14 |
| Model Number | * |
| Catalog Number | 0005290 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 140838 |
| Manufacturer | DAVOL C R BARD INC. |
| Manufacturer Address | * COVINGTON GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-01-14 |