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 that the blood set detached and leaked blood.No 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 returned for evaluation.A visual evaluation was performed on the returned set and it was noted that the backcheck valve was broken in the caresite valve.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.While an exact root cause cannot be determined, review of the complaint sample and manufacturing records suggests that the defect did not originate from a failure in the manufacturing process(es).Based on these findings the most likely potential cause is that the defect originated from excessive force being placed on the valve during use.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 400516274.The actual device involved in the reported incident was returned for evaluation.A visual evaluation was performed on the returned set and it was noted that the backcheck valve was broken in the caresite valve.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.While an exact root cause cannot be determined, review of the complaint sample and manufacturing records suggests that the defect did not originate from a failure in the manufacturing process(es).Based on these findings the most likely potential cause is that the defect originated from excessive force being placed on the valve during use.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: 11973339
• Report Number: 2523676-2021-00169
• Device Sequence Number: 11680890
• 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: company representative,health
• 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: 07/31/2023
• Device Model Number: 490438
• Device Catalogue Number: 490438
• Device Lot Number: 0061755299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/01/2021; 06/01/2021
• 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