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

Model Number BB510

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If additional information is received a follow up report will be submitted.Investigation: no product at hand.Only photos archived.We found that the sterile packaging is open at one side.Batch history review: the device quality and manufacturing history records will be checked for all the lot number (4509537648/4509299706) from the quality coordinator of the production plant.After review the report will be updated.No similar incidents have been filed with products from this batch.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.There is the possibility that the root cause of the problem is most probably manufacturing related.Rationale: without the product we cannot determine the exact cause but there is the possibility for a manufacturing error due to an improperly manufactured sealing.

Event Description

It was reported there is a crack/hole at the sterile package for two different lot numbers.The packaging problem was detected prior to surgery and all sterile packaging was checked with a lamplight.No other information has been provided.Associated medwatches: 9610612-2019-00218 (this report), 9610612-2019-00219.

• 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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8476220
• MDR Text Key: 140740834
• Report Number: 9610612-2019-00218
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: BB510
• Device Catalogue Number: BB510
• Device Lot Number: 4509537648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/26/2019
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1