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

Model Number	BM015R
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem 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).
Additional 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
• Common Device Name: DUROGRIP NEEDLEHOLDERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10028886
• Report Number: 9610612-2020-00159
• Device Sequence Number: 19757176
• Product Code: HXK
• UDI-Device Identifier: 04038653027934
• UDI-Public: 0104038653027934
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1