MAUDE Adverse Event Report: AESCULAP AG TC BAUMGARTNER NDL HLDR HVYSERR145MM; DUROGRIP NEEDLEHOLDERS

Model Number BM015R

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

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 product tc baumgartner ndl hldr hvyserr145mm.According to the description: gap in solder.There was no patient harm.Additional information was not available.The adverse malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

General information: we received a complaint about gaps in the solder at six needle holders noticed during incoming goods inspection at the customer.Consequences for the patient: according to the available information, there were no negative consequences for the patient.Investigation: investigation was carried out by ats.According to the qstd, the soldering must be complete filled and even.Batch history review: the device quality and manufacturing history records will be checked for the lot number 4510838636 from the quality coordinator of the production plant.The results of the review will be documented in (b)(4).If the review shows any conspicuities, the report will be updated and actions will be initiated.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: according to the qstd, the soldering must be free of gaps.Therefore this/these needle holders should not have passed the final inspection.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

• Brand Name: TC BAUMGARTNER NDL HLDR HVYSERR145MM
• Type of Device: DUROGRIP NEEDLEHOLDERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10028886
• MDR Text Key: 190017688
• Report Number: 9610612-2020-00159
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 04038653027934
• UDI-Public: 0104038653027934
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM015R
• Device Catalogue Number: BM015R
• Device Lot Number: 4510838636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1