MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #10; BASIC 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 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: thirty-six unopened dispenser packaging of lot 4510101361, were received.They arrived in a decontaminated condition and they are available for investigation.Investigation - the investigation was carried out visually and microscopically.We also made an optical inspection of the arrived unopened dispenser packaging.Here we detected no visible damaged dispenser packaging of the package.There were some found with suspected visible damage.Furthermore, the products were sent to the production department for further investigations.The report will be updated when we receive a statement from that department.Batch history review - the device quality and manufacturing history records will be checked for the lot number.Once the quality coordinator of the production plant checks it, the report will be updated.No similar incidents have been filed with products from these batches.Conclusion and root cause - there is the possibility that the root cause of the problem is related to an improper transport of the product.The report will be updated after further investigation from the production department.Rationale - due to the circumstance that the products have been sent to the manufacturer for an analysis, this is a preliminary report.There is the possibility that the holes or cracks and suspected visible damage were caused due to an improper transport of the product.There is also the possibility that the cause could be traced back to an increased load, e.G.Drops, impacts or similar, during transport.A capa was initiated and completed.

Event Description

It was reported that there was an issue with the scalpel package.Prior to surgery, it was noted that there was a hole or crack in the sterile packet.The device was not used on a patient.There was no additional information.

• Brand Name: CARBON STEEL SCALPEL BLADES #10
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 8601508
• MDR Text Key: 144968591
• Report Number: 9610612-2019-00315
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: BB510
• Device Catalogue Number: BB510
• Device Lot Number: 4510101361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/03/2019
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2018
• 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