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

Catalog Number	471954
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 not 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: "when the user opened the product to use, they found a black particle in the cap connected to the extension tube." no injury reported.
Additional Manufacturer Narrative
One (1) smallbore extension set in open packaging was returned in connection with this complaint.Also, a photo of one (1) female luer lock connector was provided.The sample and photo were visually inspected, and an embedded black particle was discovered on the female luer lock connector.The particulate was measured to be approximately 0.40 square millimeters in size.The set was then physically tested per specification with passing results.Incidents of embedded contamination are normally attributed to degraded/burned material that may have become trapped in the vents at the time the part was molded.Although the defect was confirmed, the particulate did not affect the product's form, fit, or function.In addition, a review of house retain samples for lot 0061594045 did not identify any further particulates or additional defects.No adverse trends related to this issue have been identified.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.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8646220
• Report Number: 9614279-2019-00083
• Device Sequence Number: 14020239
• Product Code: FPA
• UDI-Device Identifier: 04022495770103
• UDI-Public: 04022495770103
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 10/31/2022
• Device Catalogue Number: 471954
• Device Lot Number: 0061594045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1