MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-13 for EXTRACTION BAG FOR MIS 332800-000010 manufactured by Teleflex Medical.
[55154267]
(b)(4). The device is not available for investigation. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[55154268]
While pulling out the bladder, some white particles coming from the purse line fell out and were deposited inside the patient's abdomen. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[58748254]
Qn#(b)(4). Per dhr the product visistat 35w non-sterile, lot # 73b1600319 was manufactured on 02/15/2016 a total of (b)(4) pieces. Lot was released on 02/18/2016. Dhr investigation did not show issues related to complaint. Additional test performed as follows: the 13 samples were taken from the current production (visistat 35w) lot # 73k1600249, the samples were functionally tested according with the characteristics in the procedure qip-0031 tecrev21, and issue reported "stuck in stapler" was not present in the current manufacturing process. Per dhr the product visistat 35w non-sterile, lot # 73b1600319 was manufactured on 02/15/2016 a total of (b)(4) pieces. Lot was released on 02/18/2016. Dhr investigation did not show issues related to complaint. Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause. If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[58748255]
While pulling out the bladder, some white particles coming from the purse line fell out and were deposited inside the patient's abdomen. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2016-00276 |
| MDR Report Key | 5947469 |
| Date Received | 2016-09-13 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-08-05 |
| Date Mfgr Received | 2016-10-07 |
| Date Added to Maude | 2016-09-13 |
| 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 | 2016-09-13 |
| Catalog Number | 332800-000010 |
| Lot Number | 71F16D0612 |
| 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 | 2016-09-13 |