MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFLATOR SYRINGE; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	622510
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as 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
As reported by the user facility: the deflator was opened to expand the balloon.The clinician attempted to connect the balloon and the indeflator, but the recess was found to be deformed and could not be used.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used syringe without packaging was returned for evaluation.The returned inflator syringe was physically evaluated for pressure test per specification with passing results.The syringe was able to inflate per specification with passing results.The reported defect was not confirmed.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.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: INFLATOR SYRINGE
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 11332896
• Report Number: 2523676-2021-00025
• Device Sequence Number: 11038208
• Product Code: DXT
• UDI-Device Identifier: 04022495172532
• UDI-Public: 04022495172532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K902377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• 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: 01/31/2023
• Device Model Number: 622510
• Device Catalogue Number: 622510
• Device Lot Number: 0061710589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/16/2021
• 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