MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for BARD-PARKER STAINLESS STEEL BLADES SIZE 15, STERILE 371215-150 manufactured by Aspen Surgical Products, Caledonia.
[145775045]
Aspen surgical received a report from the distributor indicating that a bard-parker blade was discovered with a seal issue found by the end user. No injury or death was reported. A manufacturing lot number was available for review. A review of the dhr was completed and determined there were no non-conformance's related to the reported issue. The most probable root cause for the condition could be machine related if the set-up foil is not installed appropriately. Worn transfer bars and mechanical issues, may also result in the reported issue. Packaging process has established controls to mitigate the reported condition, including functional pull tests of the packaging for integrity. The following controls are in place to mitigate the packaging condition: functional testing, temperature control alarms, in process inspections. Additionally, the ifu which is received with the product, along with the pouch label, identifies this failure mode with the symbol "do not use if package is damaged". This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised. Based on this information, no further action is required. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[145775046]
Aspen surgical received a report from the distributor indicating that a bard-parker blade was discovered with a seal issue by the end user. No injury or death was reported. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2019-00036 |
| MDR Report Key | 8518188 |
| Date Received | 2019-04-16 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-08-15 |
| Date Added to Maude | 2019-04-16 |
| 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 | MR. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD-PARKER STAINLESS STEEL BLADES SIZE 15, STERILE |
| Generic Name | BARD-PARKER BLADE |
| Product Code | GES |
| Date Received | 2019-04-16 |
| Model Number | 371215-150 |
| Lot Number | 0171676 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-16 |