MAUDE Adverse Event Report: B BRAUN MEDICAL INC EXTENSION SET; SET, ADMINISTRATION, INTRA

Catalog Number	470073
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
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: detailed inquiry description: according to the customer, the filters they recently purchased have a powder in them, which darkens as drug is infused and they are also precipitating.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Section a: evaluator information.Evaluator name: (b)(6).Evaluator title: pir technician.Date(s) of evaluation: august 10, 2023.Section b: condition of returned samples.Sample status: [] no sample returned [x] sample returned.Pictures attached: [ ] yes [x] no.Condition of samples: one thousand one hundred two unused samples with original packaging returned for evaluation.Section c: inspection & testing of returned samples specification/test method(s): spec-md- 2000617 product drawing(s): dwg-md-2020339 safety check / service manual(s): n/a specific requirement(s): samples were visually evaluated, and it was impossible to determine the white powder inside the filter.Scan 20230817-1 was created, and samples were sent to the supplier.The supplier pall medical conducted a full nc review, and sent samples to sls lab, pall newquay; and no abnormalities or impurities were detected during the filter inspection.Equipment / apparatus: n/a test result(s): [ ] defect confirmed [x] defect not confirmed results description: the reported defect is not confirmed.Section d: record review related dsms records identified: [ ] yes [x] no [] n/a - not enough info for evaluation dsms report / criteria: usa qm_11.Dsms results description: n/a.Existing capa to address issue?: [ ] yes [x] no.Product produced before or after corrective action implementation?: [ ] before [ ] after [x] n/a details of existing capa: n/a.Section e: batch record (br) review: br applicability: [x] n/a - not required [ ] applicable were all related test results in specification?: [ ] yes [ ] no [x] n/a - not required were all related process parameters in specification?: [ ] yes [ ] no [x] n/a - not required were all operations completed and done in sequence?: [ ] yes [ ] no [x] n/a - not required explain any "no" answers: [x] n/a - not required.Section f: inspection & testing of house retains applicability: [x] n/a - not required [ ] applicable.Specific requirement(s): n/a equipment / apparatus: n/a test result(s): [ ] defect confirmed [ ] defect not confirmed.[x] n/a - not required.Results description: [x] n/a - not required.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B BRAUN MEDICAL INC; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B BRAUN MEDICAL INC; 901 marcon blvd.; km22 autopista las americas; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17395828
• Report Number: 2523676-2023-00375
• Device Sequence Number: 12676876
• Product Code: FPA
• UDI-Device Identifier: 04046964298219
• UDI-Public: (01)04046964298219
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 470073
• Device Lot Number: 0061873343
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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