MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #15

Model Number BB515

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: we received 250 carbon steel scalpel blades #15: 236, unopened, no deviation found with the naked eye.4, no deviation found with the naked eye-opened by customer.5, anti-rust inlay misplaced- opened by customer.3, anti-rust inlay misplaced- opened by vigilance investigator.2, unopened, but without lot stamp.One pack included two blades the peel packaging of eight blades are not sealed correctly since the anti-corrosion-inlay is not at the right position.Batch history review the device quality and manufacturing history records for the available lot numbers have been requested at the responsible q-coordinator of the production plant.The answer is still pending.This report will be updated upon receipt of the review confirmation.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of out investigation the root cause of the failure is related to a manufacturing error.Rationale the detected error can be attributed to a production error.A capa has been initiated.

Event Description

It was reported insufficient sealing.The reporter indicated during surgery the blade packages were looked at and it was found they were not sealed resulting in a sterility problem.No patient harm.Additional information has been requested, however, not yet received.

• Brand Name: CARBON STEEL SCALPEL BLADES #15
• Type of Device: SCALPEL BLADES
• 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 ; 8002581946
• MDR Report Key: 8671889
• MDR Text Key: 147477119
• Report Number: 9610612-2019-00360
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/05/2019

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 Expiration Date: 05/31/2023
• Device Model Number: BB515
• Device Catalogue Number: BB515
• Device Lot Number: 4509746734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/27/2019
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2018
• 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