MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BLOOD ADMINISTRATION SET; STOPCOCK, I.V. SET

Model Number	490438
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 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: end user reports, leaking at bottom of hand pump while squeezing, required set change.No patient injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation, however a picture was provided.Visual examination of the picture noted that the two segments shown do not appear to be related to reported item.The picture was compared with components listed in product drawing and no matches were able to be made.The batch record was reviewed and the batch met and passed all release criteria and tests.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Retained units for batch 0061759419 passed internal testing.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.This follow-up is being filed to correct the b.Braun medical internal report number.The number has been corrected to (b)(4).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation, however a picture was provided.Visual examination of the picture noted that the two segments shown do not appear to be related to reported item.The picture was compared with components listed in product drawing and no matches were able to be made.The batch record was reviewed and the batch met and passed all release criteria and tests.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Retained units for batch 0061759419 passed internal testing.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: BLOOD ADMINISTRATION SET
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11973338
• Report Number: 2523676-2021-00170
• Device Sequence Number: 14491729
• Product Code: FMG
• UDI-Device Identifier: 04046964833441
• UDI-Public: 04046964833441
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2021

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: 09/30/2023
• Device Model Number: 490438
• Device Catalogue Number: 490438
• Device Lot Number: 0061755102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 06/02/2021; 06/02/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/30/2021; 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1