MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRA

Model Number	354210
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 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: it was reported that a hair was seen inside the iv set.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Initially one photograph was provided without lot information.Sample with packaging identifying lot# 0061683046 was received.Visual examination of the sample noted a hair present in the drip chamber.The provided photo displays the same defect.Based on the evaluation of the sample the reported defect is confirmed.The universal vented spike is a purchased part.The sample and all relevant information was forwarded to the supplier for further investigation.Based on the suppliers response, the molding area manager and assembly manager has informed all production employees about this occurrence.Shift managers have been requested to put max attention to notify any deviation in the application of the dressing procedure.We will maintain this report for further references and continue to monitor other reports for similar occurrences.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.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: IV ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 9580663
• Report Number: 9614279-2019-00239
• Device Sequence Number: 10899185
• Product Code: FPA
• UDI-Device Identifier: 04046964182174
• UDI-Public: 04046964182174
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• 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): 03/30/2020

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: 06/30/2022
• Device Model Number: 354210
• Device Catalogue Number: 354210
• Device Lot Number: 0061683046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1