MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER DISPOSABLE SCALPELS SIZE 10, STERILE; BARD-PARKER BLADE

Model Number 371610-100

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was not returned for evaluation.The manufacturing lot number and photographic evidence was provided for review.A review of the photographic evidence confirmed the issue from the end user.Analysis of the finished good lot number was reviewed.No non-conformance's were noted during the manufacturing process.According to the manufacturing process, these parts are inspected for any non-conforming product as part of the packaging machine per specified work instructions.Therefore a likely root cause for the defect may be attributed to an operator error.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.Additionally, production supervisors and operations were notified of this issue.Based on this information, no further action is required.Device not returned.

Event Description

Aspen surgical received a report from the distributor indicating that the product was discovered with an incomplete seal.Issue was discovered at the end user.Item was not in use and no adverse event was reported.The reported issue has been filed under the complaint handling system for number (b)(4).

• Brand Name: BARD-PARKER DISPOSABLE SCALPELS SIZE 10, STERILE
• Type of Device: BARD-PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 15320288
• MDR Text Key: 303408189
• Report Number: 1836161-2022-00023
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371610-100
• Device Lot Number: 0261680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1