MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-22 for BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE 371111-150 manufactured by Aspen Surgical Products, Caledonia.
[145838698]
Aspen surgical received a report indicating that a bard-parker blade detached while in use during a procedure. The incident occurred at the user facility. No manufacturing lot number or sample were provided for review. End user indicated that following a left shoulder arthroscopy, the surgical blade was retained in the patient's left shoulder for several days post discharge. The patient experienced post op discomfort and was evaluated in the emergency room and discharged. Several days later, patient was seen by the surgeon for post op visit where x-rays were obtained and noted the retained blade. The retained blade was surgically retrieved successfully. No further patient follow up required. Due to no manufacturing lot number provided, a review of the device history record could not be completed. The most probable root cause could be contributing to blade detached from handle condition where the handle could be damaged. However, this could not be verified due to no return in sample. Additionally, excessive force applied by the end user during surgery process could contribute to the condition. The following controls are in-place to mitigate blade detached from handle 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. No sample was available for return. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[145838699]
Aspen surgical received a report from the distributor indicating that a bard-parker blade detached 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 | 1836161-2019-00040 |
| MDR Report Key | 8633251 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-22 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-05-22 |
| 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 |
| 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 11, STERILE |
| Generic Name | BARD-PARKER BLADE |
| Product Code | GES |
| Date Received | 2019-05-22 |
| Model Number | 371111-150 |
| 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 | 2019-05-22 |