MAUDE Adverse Event Report: AESCULAP AG TC DE'BAKEY NDL HOLDER DEL SERR 230MM; BASIC INSTRUMENTS

Model Number	BM036R
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: a gap in the solder at the working end can be found.Furthermore damages at the male box lock.Vigilance investigator carried out the pictorial documentation visually and microscopically.A gap at the tip of the needle holder can be found.According to the quality standard, the solder must be even and completely filled.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the lot number(s) from the quality coordinator of the production plant.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and root cause: the solder is not according to the specification valid at the time of production.Due to the investigation results the root cause is most probably manufacturing related.The current failure rate is within the risk analysis and therefore acceptable.Corrective action/ preventiv action: at the moment it looks like an error in production/ qa.It must be checked whether the solder was according to the specifications at the time of production.Q-coordinator of production plant will be informed.It must be checked by the responsible q-coordinator and appropriate measures must be taken.
Event or Problem Description
It was reported that there was an issue with bm036r - tc de'bakey ndl holder del serr 230mm.According complaint description it was reported that the instruments entered the qa process at hospital.Item was accessed and the failure was found.Visible gap in solder that adheres the tc insert.There was no patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under (b)(4).

• Brand Name: TC DE'BAKEY NDL HOLDER DEL SERR 230MM
• Common Device Name: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10792120
• Report Number: 9610612-2020-00560
• Device Sequence Number: 14286438
• Product Code: HXK
• UDI-Device Identifier: 04038653028108
• UDI-Public: 4038653028108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: A883082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BM036R
• Device Catalogue Number: BM036R
• Device Lot Number: 4511630994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1