MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-12 for DYNJWE1310 manufactured by Medline Industries.
[2600756]
Surgical drain broke as it was being inserted. The broken pieces were removed without injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
[9746412]
The surgical drain was being inserted during a lap chole procedure due to unanticipated pt bleeding. The surgeon was using one of three graspers with serrated jaws from another mfr to pull the drain into place. The surgical tech reported hearing a pop and two pieces of the drain broke off. Both pieces were removed with video assistance without further incident. The main portion of the drain was left in place and it was reported that the pt did well. The two broken pieces were returned for eval. The broken edges were jagged in appearance. One piece measured 1. 25 inches and the other piece was 0. 25 inches long. Stress marks were seen on the returned pieces of the drain which may have been caused by the device used to pull it. We contacted the mfr of the graspers and were informed that none of the three mentioned graspers are part of their atraumatic line. The amount of force being used with the grasper is not known. Aggressive force combined with use of the serrated jaws has been determined to be the most likely cause of the reported incident. We have had no other similar reports of a drain breaking upon insertion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2012-00010 |
| MDR Report Key | 2507414 |
| Report Source | 05,06 |
| Date Received | 2012-03-12 |
| Date of Report | 2012-03-07 |
| Date of Event | 2012-02-09 |
| Date Mfgr Received | 2012-02-10 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-08-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SILICONE DRAIN |
| Product Code | GBW |
| Date Received | 2012-03-12 |
| Returned To Mfg | 2012-03-01 |
| Model Number | DYNJWE1310 |
| Lot Number | P1118190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-12 |