MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD PARKER SAFETY BLADES SIZE 20, STERILE; SCALPEL BLADE

Model Number	373920
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation.No picture was provided, however the lot number was provided for the investigation.Based on this, the ability to investigate was limited.However, based on what we can tell, there most likely was a manufacturing error which led to the safety device not engaging properly.In addition, the user did not follow the instructions for the product, and this contributed to the hand injury that occurred.Per the ifu (instructions for use), it says "if safety shield or housing malfunctions, dispose and replace product" as well as "do no use product if product is damaged".In this case, the physician already had noted that the safety mechanism was not working properly and warned the scrub nurse to be careful, so they were aware that the safety mechanism was not working properly and proceeded to continue using the product.Based on all of this and our limited potential for investigating, the malfunction of the safety mechanism was most likely caused by a manufacturing error while the injury that occurred after the malfunction was identified was most likely caused by the user not following the use instructions for the device.This should be considered the final report, however if we identify additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "we received scalpel blades in the c section packs from pdl.This morning during a cs the physician made a comment to the scrub to "be careful, the safety won't engage on the blade".The scrub was setting up for the next case, when she put the knife handle on the blade, the safety disengaged and cut her hand badly.The nurse received sutures and a splint in the ed.She had her appointment with the hand surgeon, and she will require surgery on her hand and will be out of work for up to 3 months.".

• Brand Name: BARD PARKER SAFETY BLADES SIZE 20, STERILE
• Common Device Name: SCALPEL BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 20859092
• Report Number: 3002750084-2024-00054
• Device Sequence Number: 17109380
• Product Code: GES
• UDI-Device Identifier: 00840113203178
• UDI-Public: 00840113203178
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 373920
• Device Lot Number: 0363631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown