MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-08-25 for DEK BL MF 0 TC-43/HR 26 2N 36" 833-124 manufactured by Teleflex Medical.
[24003504]
(b)(4). The device history review could not be conducted since the lot number was not provided. The device sample has not been returned to the manufacturer for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[24003506]
Alleged event: the harpoon broke and was left inside the patient. To insert the suture, a capio was used. A new capio and a new suture was used. At the second attempt the harpoon needle probably got stuck in capio. The harpoon needle was not found and a thread stuck out of the capio. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[41059885]
(b)(4). One samples of part number 543965 arrived without the original packaging. Lot number was confirmed as 73m1400228. Visually the applier had a slightly disassembled knob, the cause for this is unknown. The sample was tested for functionality: the applier was activated and the clips were released correctly and closed correctly without any issues. Then 4 more clips were activated using tubing and they all closed and released correctly. In total 5 clips were fired and all clips closed and release correctly. Defect reported "does not grab skin properly" could not be confirmed. Per functional testing of applier part number 543965, 5 clips were fired and closed and release correctly. Defect reported "does not grab skin properly" could not be confirmed. Therefore, corrective actions is not required at this time. However, we will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[41059886]
Alleged event: the harpoon broke and was left inside the patient. To insert the suture, a capio was used. A new capio and a new suture was used. At the second attempt the harpoon needle probably got stuck in capio. The harpoon needle was not found and a thread stuck out of the capio. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00231 |
| MDR Report Key | 5029270 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-08-25 |
| Date of Report | 2015-07-28 |
| Date of Event | 2015-07-22 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2015-08-25 |
| 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 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEK BL MF 0 TC-43/HR 26 2N 36" |
| Generic Name | SUTURE |
| Product Code | OVN |
| Date Received | 2015-08-25 |
| Returned To Mfg | 2016-02-24 |
| Catalog Number | 833-124 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-25 |