MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-30 for OB DELIVERY PK DYNJ16715 * manufactured by Medline Industries, Inc..
[520971]
The ear / ulcer bulb syringes reportedly do not re-inflate after compression resulting in the inability to suction infant airways at the time of delivery. Report source states that this has occurred approximately 4 times. The infants have not experienced any adverse effects as staff was able to quickly obtain a functioning syringe.
Patient Sequence No: 1, Text Type: D, B5
[7793606]
The ear/ulcer bulb syringes are not available for evaluation. This item is made by amsino for medline and added to the ob delivery packs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423395-2006-00011 |
| MDR Report Key | 778604 |
| Report Source | 05 |
| Date Received | 2006-10-30 |
| Date of Report | 2006-10-18 |
| Date Mfgr Received | 2006-10-18 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-11-09 |
| 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 | 0 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PL |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OB DELIVERY PK |
| Generic Name | EAR/ULCER BULB SYRINGE IN SURGICAL PACK |
| Product Code | KCB |
| Date Received | 2006-10-30 |
| Model Number | DYNJ16715 |
| Catalog Number | * |
| Lot Number | 06AD2092 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 766379 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Baseline Brand Name | OB DELIVERY PK |
| Baseline Generic Name | EAR/ULCER BULB SYRINGE IN SURGICAL PACK |
| Baseline Model No | DYNJ16715 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-30 |