MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; NEEDLE, HYPODERMIC, SINGLE

Model Number	7G0400
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The 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 1: it was reported that the transfer device was deformed.No patient involvement.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).A total of 9 unused samples without packaging were provided for further evaluation.The samples were inspected and 1 out of the 9 samples were confirmed for damaged tips.Further investigation was performed in order to determine a root cause for the damaged tip.Demand maintenance records for the finished good lot as well as the manufactured component lots were reviewed and no records were found which would lead to a machine causing the defect.In terms of users, the defect was found during the customer's incoming inspection, and therefore no user could have caused the defect.Additionally, a review of b.Braun personnel was also performed.All procedures in placed were being followed.Batch records for the associated finished goods and components/materials were also reviewed and no non-conformances were found.This defect is not related to the environment or the measurement system.Damaged tips are most-likely caused by blunt force to the tip.The molding process uses a chute and conveyor to minimize the impact to the tip as much as possible.The assembly process uses a wider shroud during siliconization and an off-chute specifically designed to avoid tip damage to minimize the impact to the tip as much as possible.Retained units were evaluated and passed the internal testing.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.While we are able to confirm the exact root cause of the reported defect; 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: NEEDLE, HYPODERMIC, SINGLE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12655967
• Report Number: 2523676-2021-00339
• Device Sequence Number: 7685592
• Product Code: FMI
• UDI-Device Identifier: 04046964345388
• UDI-Public: (01)04046964345388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K801108
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2021

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: 07/31/2026
• Device Model Number: 7G0400
• Device Catalogue Number: 7G0400
• Device Lot Number: 00VL795567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown