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

Catalog Number	490314
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (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.It should be noted that the end user has three (3) possible batch numbers in stock: however, it is unsure which batch number was used.The possible batch numbers are: batch number: 0061616195, production date: (b)(6) 2018, expiry date: 03/31/2021; batch number: 0061609598, production date: (b)(6) 2018, expiry date: 02/28/2021; batch number: 0061592311, production date: (b)(6) 2017, expiry date: 10/31/2020.
Event or Problem Description
As reported by the user facility: it was stated that the patient noticed the foreign body in the tubing, and that it "looked like an ant".Infusion was immediately stopped and the tubing removed.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample with no packaging was returned for evaluation.The sample was visually examined under magnification and no particulate or foreign matter was able to be observed.However, photos returned by the facility did confirm a dark foreign particulate in the fluid path of the tubing.Although the reported defect was confirmed via the photos, the exact root cause could not be determined at this time.Review of the discrepancy management system (dsms) database performed for the possible lot numbers revealed no abnormalities or non - conformances noted during in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: BLOOD ADMINISTRATION SET
• 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: 7751470
• Report Number: 9614279-2018-00118
• Device Sequence Number: 1835924
• Product Code: FPA
• UDI-Device Identifier: 04046964527180
• UDI-Public: 04046964527180
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• 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): 08/28/2018

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: 490314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1