MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-01 for CODMAN CLASSIC PLUS NEEDLE HOLDER 36-3001 manufactured by Symmetry Surgical Formerly Codman & Specialty Surgical Instrumentation.
[3428393]
During a peritoneal dialysis catheter placement procedure, it was noted that a needle holder inside jaw was missing. It was unk if the needle holder was intact at the beginning of the case. An abdominal x-ray was taken and read as negative by radiologist as "no foreign body seen. " there was no harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2013-00002 |
| MDR Report Key | 3070235 |
| Report Source | 06 |
| Date Received | 2013-04-01 |
| Date of Report | 2013-04-01 |
| Date of Event | 2013-02-11 |
| Date Mfgr Received | 2013-03-06 |
| Device Manufacturer Date | 1991-04-01 |
| Date Added to Maude | 2013-05-30 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTIN MOORE |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 6159645392 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN CLASSIC PLUS NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2013-04-01 |
| Model Number | 36-3001 |
| Lot Number | 9104N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL FORMERLY CODMAN & SPECIALTY SURGICAL INSTRUMENTATION |
| Manufacturer Address | ANTIOCH TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-01 |