MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-03 for MUELLER PHLEB HK RGHT SZ1 4-3/4 IN PHLEBECTOMY HOOK X21432 manufactured by Integra York, Pa Inc..
[74513628]
Integra has completed their internal investigation on april 25, 2017. Results: evaluation of returned device; there were two hooks in used condition, not showing any unusual markings. During the analysis of the returned hooks, it is noticed the hooks are showing wear, spotting within the finish and tips broken. Per end users complaint the breakage occurred during use of the instrument. This type of damage to the tips can happen if too much pressure is used. Dhr review; nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Complaints history; a two year look back in trackwise found a total of 0 complaints for item x21432, for failures related to broken during use. Conclusion: there were two hooks returned used/processed showing wears, spotting and broken tips. The complaint report has been confirmed; the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[74513629]
Customer initially reports 3 of the 6 instruments broke during first use. On 4/13/2017 customer reports device tips broke off during a vein ligation and stripping left leg, no patient harm, tips retrieved. Number 2 of 2 related complaints same patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00050 |
| MDR Report Key | 6541555 |
| Date Received | 2017-05-03 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2017-05-03 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MUELLER PHLEB HK RGHT SZ1 4-3/4 IN PHLEBECTOMY HOOK |
| Generic Name | JARIT |
| Product Code | GAI |
| Date Received | 2017-05-03 |
| Returned To Mfg | 2017-04-17 |
| Catalog Number | X21432 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-03 |