MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-22 for BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE 371115-150 manufactured by Aspen Surgical Products, Caledonia.
[142672295]
Aspen surgical received a letter from the fda (uf/importer report # (b)(4)) indicating that item number 371115 bard-parker blade broke in a patient during a procedure. The incident occurred at the user facility. A manufacturing lot number was provided for review. A review of the device history record was completed and no non-conformances related to the reported issue were identified. The most probable root cause could have been machine related during the stamping or grinding process. Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging. Also, excessive force applied by the end user during surgery process could cause blade breakage. The following controls are in-place to mitigate "broken blade" condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test. Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test. No sample was returned and no additional information was provided from the end user. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[142672296]
Aspen surgical received a letter from the fda (uf/importer report # (b)(4)) indicating that item number 371115 bard-parker blade broke in the patient during a procedure. Incident occurred at the end user. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2019-00037 |
| MDR Report Key | 8536456 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-22 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2018-05-07 |
| Date Added to Maude | 2019-04-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE |
| Generic Name | BARD-PARKER BLADE |
| Product Code | GES |
| Date Received | 2019-04-22 |
| Model Number | 371115-150 |
| Lot Number | 0164104 |
| 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 | 1. Other; 2. Required No Informationntervention | 2019-04-22 |