MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-08-28 for IDRT TS INTL 5PK 8X10 88105 manufactured by Integra Lifesciences Corp..
[4758252]
It was reported "in the box of 5 idrt, one of the idrt had yellow dots on the sealing. The customer did not use it per caution. The device was not in contact with any patient. The event did not lead to an increase of surgery time. "
Patient Sequence No: 1, Text Type: D, B5
[12372120]
Integra has completed their internal investigation on 08/25/2014. Results: evaluation of complaint related device revealed stains were present on the tyvek pouch. The tear and leakage from the foil pouch likely occurred during shipping, as this product has undergone 100% inspection after sterilization and boxing processes. A review of the manufacturing records for lot 105b00286508 revealed the date of manufacture is 08/16/2013. There are no non-conformances related to idrt-ts 8x10, lot 105b00286508. (b)(4). Conclusion: root cause: it was determined that the most likely cause of this defect was due to the booklet pressing against the top left corner of the foil pouch insert. Repeated pressing caused a tear to occur and resulted in buffer leakage, causing the yellow dots observed. The root cause of the leakage was likely due to the booklet pressing against the foil pouch insert during shipping. Capa has been initiated to address this failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00050 |
| MDR Report Key | 4102669 |
| Report Source | 05,06,07 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-07-02 |
| Date Mfgr Received | 2014-08-26 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-09-29 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT TS INTL 5PK 8X10 |
| Generic Name | INTEGRA |
| Product Code | MGR |
| Date Received | 2014-08-28 |
| Returned To Mfg | 2014-07-14 |
| Catalog Number | 88105 |
| Lot Number | 105B00286508 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-28 |