MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for EXTRACTION BAG FOR MIS 332800-000010 manufactured by Teleflex Medical.
[62801100]
(b)(4) the device is unavailable for investigation. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[62801101]
During the surgical procedure it was not possible to recover the bag because it disintegrated. The contents of the bag spilled into the peritoneal cavity. The peritoneal cavity was aspirated but the bag was not recovered. It was reported that there was no immediate consequence for the patient.
Patient Sequence No: 1, Text Type: D, B5
[65500201]
(b)(4). Customer complaint regarding memobag product was reported. As the lot number of the defective product was reported, the dhr review was completed. The review of dhr revealed no production issues at the time of manufacture of the complained lot. Reported defect cannot be confirmed because of unavailable defective device. The root cause of this complaint cannot be clearly determined based on provided information from the customer/user (bag did not burst, but bag disintegrated) and unavailable defective device. As the root cause of this complaint was not determined, no corrective/preventive actions in production are deemed necessary to introduce.
Patient Sequence No: 1, Text Type: N, H10
[65500202]
During the surgical procedure it was not possible to recover the bag because it disintegrated. The contents of the bag spilled into the peritoneal cavity. The peritoneal cavity was aspirated but the bag was not recovered. It was reported that there was no immediate consequence for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2016-00380 |
| MDR Report Key | 6175515 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2017-01-10 |
| Date Added to Maude | 2016-12-15 |
| 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 | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | ARROW INTERNATIONAL CR, A.S. |
| Manufacturer Street | JAMSKA 2359/47 |
| Manufacturer City | ZDAR NAD SAZAVOU 591 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 591 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTRACTION BAG FOR MIS |
| Product Code | KGY |
| Date Received | 2016-12-15 |
| Catalog Number | 332800-000010 |
| Lot Number | 71F16K1015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-15 |