MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #22; BASIC INSTRUMENTS

Model Number BB522

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: the peel packaging of the blades are not sealed correctly.One side of the peel is open, the anti-corrosion-inlay is not at the right position.Batch history review: the device quality and manufacturing history record have been checked for the available lot number and found to be according to our specifications valid at the time of production.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 our investigation the root cause of the failure is most probably related to a manufacturing error.Rationale: the detected error can be attributed to a production error.

Event Description

It was reported the packages had insufficient sealing.The reporter indicated that in almost every case the packages of the scalpel blades were completely open.The blades were falling out of the package.This event was noticed prior to surgery, therefore no harm to the patients.

• Brand Name: CARBON STEEL SCALPEL BLADES #22
• 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 ; 8002581946
• MDR Report Key: 8660347
• MDR Text Key: 147164820
• Report Number: 9610612-2019-00363
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 05/31/2019

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: 07/31/2023
• Device Model Number: BB522
• Device Catalogue Number: BB522
• Device Lot Number: 4509960181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/21/2019
• Device Age: 5 MO
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1