MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. FILTERFLOW®; SET, ADMINISTRATION, INTRA

Catalog Number	352205
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has 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: customer reports that the inline filter appears to have a dry rotted or contaminated injection site.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unopened set was returned for evaluation.Visual examination of the set noted the injection stopple to appear degraded damaged.The reported defect of white particulate on the injection stopple was not confirmed.However, the stopple of the injection site was confirmed to be degraded/damaged.The five retain samples were visually evaluated per specification.One of the five retain samples was found to have a damaged defective injection site as confirmed from the visual inspection of the original sample.The before lot 0061561112 and after lot 0061579731 were also visually and functionally tested and found acceptable.The root cause of the degraded and discolored injection site was determined to be the result of overheated during the production manufacturing process.Incidents of this nature are attributed to operator oversight during the production and inspection of the product.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.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.A follow up will be submitted when the investigation results become available.

• Brand Name: FILTERFLOW®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 8484481
• Report Number: 9614279-2019-00036
• Device Sequence Number: 11266390
• Product Code: FPA
• UDI-Device Identifier: 04046964181245
• UDI-Public: 04046964181245
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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: 05/31/2022
• Device Catalogue Number: 352205
• Device Lot Number: 0061570386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1