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

Model Number	470108
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event 2 of b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
Event 2: as reported by the user facility: "when connecting the tubing, there is no tightness.Blood flows at the level of the screw.".
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).This product was distributed in the eu only and the identified issue had no impact on product available in the u.S.Market.Five used samples were provided for evaluation.Visual examination noted no defects.Leak test was performed and one sample failed.Upon closer examination the sample appears to have been solvent bonded between the spin lock and luer connector which did not allow the connector to seal properly.Signs of solvent were also found on the male luer lock connector.Based on the evaluation of the samples the reported defect is confirmed.Based on the investigation the issue is related to the solvent bonding process during hand assembly.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, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 11020324
• Report Number: 2523676-2020-00354
• Device Sequence Number: 869624
• Product Code: FPA
• UDI-Device Identifier: 04046964093753
• UDI-Public: 04046964093753
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/25/2021

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: 06/30/2023
• Device Model Number: 470108
• Device Catalogue Number: 470108-01
• Device Lot Number: 0061744004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1