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

Model Number	470106
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
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 there was something like lint or hair in the connector site attached to the valve.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) photographs of the sample were provided for evaluation.Visual examination of the photographs noted a particulate on the set.Based on the evaluation of the photographs the reported defect is confirmed.The house retain samples were functionally and visually tested and no defects were confirmed.Incidents of this nature are attributed to operator oversight during the packaging 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.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.In addition, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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: CARESITE
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10175321
• Report Number: 2523676-2020-00167
• Device Sequence Number: 14116878
• Product Code: FPA
• UDI-Device Identifier: 04046964093739
• UDI-Public: 04046964093739
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083723
• 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): 07/31/2020

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: 12/31/2022
• Device Model Number: 470106
• Device Catalogue Number: 470106
• Device Lot Number: 0061714091
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1