MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #10

Model Number BB510

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with carbon steel scalpel blades.There are cracks/hole in the sterile packet.The holes appear usually 1 in every 20-30 blades that are opened.This happens with different lot numbers and batches.The facility staff are therefore uncertain of the sterility of this product.This was the same type of problem as in march and april this year.(reported earlier) there was no patient harm.Additional information was not provided.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Batch history review: the traceability of articles with batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer.In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to the transport and storage of the product.Rationale: according to the information available, the most probable cause of the reported damages of the package are related to transport and storage of the product.As the products are not available for investigation the holes cannot be confirmed, known from other complaint ((b)(4)) it is possible, that deformations on the aluminum package are misinterpreted as holes.Corrective action: capa 700002796 has been conducted and implemented.

• Brand Name: CARBON STEEL SCALPEL BLADES #10
• Type of Device: SCALPEL BLADES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9528470
• MDR Text Key: 179469587
• Report Number: 9610612-2019-00885
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/19/2020

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: BB510
• Device Catalogue Number: BB510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/28/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1