MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. FILTER HUB; NEEDLE, ASPIRATION AND INJ

Catalog Number	418021
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: it appears that the glue is flaking and allowing particulate to fall off.No injury reported.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Sixteen (16) samples and two (2) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, flaking around the seal area was observed; however, no glue was used on the manufacturing end during the sealing process.Through visual examination of the received samples, it was noted that small pieces of paper inside the blister was observed.It was determined that the particulate was paper.Based on the investigation, the reported defect is confirmed.While a defect was confirmed, an exact root cause could not be determined.The most probable root cause of the reported event is the flaking coming off from the packaging seal.Machines seal the product and no glue is used during this process.Since there were only 16 out of 35,000 blister packs affected, this event is considered an isolated incident.A review of the non-conformance system database was performed for the reported lot number and no abnormalities or nonconformances 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: FILTER HUB
• Common Device Name: NEEDLE, ASPIRATION AND INJ
• 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: 18443456
• Report Number: 2523676-2023-00864
• Device Sequence Number: 18186147
• Product Code: GAA
• UDI-Device Identifier: 04022495769985
• UDI-Public: (01)04022495769985
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Catalogue Number: 418021
• Device Lot Number: 0061865393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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