MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SYRINGE CAPS; SYRINGE, PISTON

Model Number	418013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
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: event 2: it was reported that there was risk of cytotoxic exposure to the staff due to defective caps.No injury reported.
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).Although no samples were returned, one photo was provided for further evaluation.The photo was visually evaluated per specification and cracks were noted at the center of the cap.Several attempts were made to replicate the defect with house retain samples.We were only able to replicate the defect when we intentionally overtightened the cap while screwing it with the syringe.The defect of caps broken has not been confirmed.The house retains were visually evaluated per specification and no defects were noted.The luers of the caps were verified to be within specification.The caps were then screwed on to b braun omnifix syringe with passing results.No cracking or leakage was noted.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: SYRINGE CAPS
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11726758
• Report Number: 2523676-2021-00101
• Device Sequence Number: 3846536
• Product Code: FMF
• UDI-Device Identifier: 04046964815225
• UDI-Public: 04046964815225
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K801311
• 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): 06/23/2021

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: 12/31/2024
• Device Model Number: 418013
• Device Catalogue Number: 418013
• Device Lot Number: 0061713493
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1