MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #10; GENERAL SURGICAL INSTRUMENTS

Model Number BB510

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

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 blade.Following information was reported: a new box of blades had been ordered and was spot-tested.Pin holes were not detected at the distribution center.However, the customer reported that the holes appear usually in 1 of every 20-30 blades opened.The product was not used on a patient.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Investigation: one out of hundred sterile packages for scalpel blade shows a hole in the aluminum foil.Vigilance investigator carried out the pictorial documentation visually and microscopically1.In total the whole package with 100 scalpel blades has been received for investigation.Fifty scalpel blades have been opened yet, the blades has been sent in a separate box and the opened aluminum foils have been sent in, too.Other fifty blades have been sent unopened.The unopened blades didn't show any pinhole or piercing on the aluminum.The opened ones did show an apparently pinhole in 4 samples.But the foil is not pierced.One sample did show a pinhole on the aluminum foil caused by the scalpel blade's tip.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 pinholes of the aluminum foil are related to transport and storage of the product.According to the implemented quality standard in the manufacturing process, at this stage of investigation a manufacturing related material defect and production error can be excluded.In relation to the produced and sold units the actual occurrence of such complaints is very low.The half of the total 13 complaints have been received from the same customer from norway.As we do not know the exact transport situation from our stock to the end customer it isn't possible to determine the exact root cause for this transport damage.As the negative influence of transport is known a security hint has been placed on the sterile package.Corrective action: capa has been conducted and implemented.

• Brand Name: CARBON STEEL SCALPEL BLADES #10
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9643122
• MDR Text Key: 179494329
• Report Number: 9610612-2019-00933
• 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: 02/26/2020

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
• Device Lot Number: 4510886571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1