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

Model Number	622510
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
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: it was reported that when the user tried to pressurize to expand the balloon, the handle did not turn well and he felt uneasy about the product and stopped using it.A new product was used without any problems.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used inflator syringe without package was provided for further evaluation.The returned inflator syringe was visually evaluated per specification by subject matter experts (smes).Based on the evaluation results, it was noted that the green wing (locking mechanism) was tightened.The evaluation suggest that the threads were damaged during tightening.No manufacturing defects were noted by sme.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: NA
• Common Device Name: INJECTOR AND SYRINGE, ANGI
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 12074655
• Report Number: 2523676-2021-00201
• Device Sequence Number: 4154598
• 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): 08/28/2021

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: 05/31/2023
• Device Model Number: 622510
• Device Catalogue Number: 622510
• Device Lot Number: 0061733369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1