MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-02-03 for ASPIRATING NEEDLE * 50-7453 manufactured by Pilling Weck Surgical.
[153461]
Pt underwent mediastinscopy in the or. Following the procedure, while surgical instruments were being decontaminated, it was noted that needle was missing from the end of needle tip aspirator. Chest x-ray revealed approx 1 cm long, 1 mm thick needle to the right side of mediastinum. Pt was returend to surgery for unsuccessful attempt to retrieve needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515651-1999-00001 |
| MDR Report Key | 208881 |
| Report Source | 07 |
| Date Received | 1999-02-03 |
| Date of Report | 1999-01-28 |
| Date of Event | 1998-12-10 |
| Date Mfgr Received | 1999-01-04 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1999-02-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIRATING NEEDLE |
| Generic Name | ESOPHAGEAL |
| Product Code | GDM |
| Date Received | 1999-02-03 |
| Returned To Mfg | 1999-01-25 |
| Model Number | * |
| Catalog Number | 50-7453 |
| Lot Number | * |
| ID Number | DATE CODE DD7 4/97 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 202716 |
| Manufacturer | PILLING WECK SURGICAL |
| Manufacturer Address | 420 DELAWARE DRIVE FORT WASHINGTON PA 19034 US |
| Baseline Brand Name | ASPIRATING NEEDLE |
| Baseline Generic Name | NEEDLE, ASPIRATION & INJECTION, REUSABLE |
| Baseline Model No | 50-7453 |
| Baseline Catalog No | 50-7453 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-02-03 |