MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EXTENSION SET; SET, ADMINISTRATION, INTRA

Model Number	471954
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: it was reported that thread particles were found in the green connector.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample in open packaging and one (1) photo were provided for evaluation.Upon visual examination of the provided materials, a white string-like particulate was observed in the fluid path of the luer connector.Upon further analysis of the particulate, it was determined to have come from the m1180601 cap that is installed on the luer connector.Retained samples from the reported batch number were evaluated per specification with passing results.Also, review of the discrepancy management system (dsms) database performed for the reported lot numbers revealed no abnormalities or non-conformances noted during in process or final product inspection.A review of the batch history records was also performed and no non-conformances or deviations were noted.Incidents of this nature are attributed to operator oversight during the molding process of the product.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.As a result of this occurrence, a quality alert was created and posted for all personnel involved with the molding and inspection processes.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10394112
• Report Number: 2523676-2020-00231
• Device Sequence Number: 19750093
• Product Code: FPA
• UDI-Device Identifier: 04022495770103
• UDI-Public: 04022495770103
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K942988
• 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,Followup
• Report Date (Section B): 09/30/2020

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 Expiration Date: 02/28/2025
• Device Model Number: 471954
• Device Catalogue Number: 471954
• Device Lot Number: 0061722084
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/11/2020
• Supplement Date Received by Manufacturer: 07/11/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1