MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISPENSING PIN; SET, I.V. FLUID TRANSFER

Catalog Number	413500
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as (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: it was reported that particulate matter was seen floating in bag in use with the dispensing pin.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused and unopened dp3500 disp pin ls reflux with packaging was returned for further evaluation.Visual examination of the dispensing pin notes no white particulates on the dispensing pin or within the blister.The defect of white particulates/plastic shavings is not confirmed.Based on the results of the sample evaluation, no specific conclusions can be made regarding the cause of the reported event.While we are unable to determine the root cause of the reported defect, we will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: DISPENSING PIN
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8037422
• Report Number: 2523676-2018-00095
• Device Sequence Number: 16502757
• Product Code: LHI
• UDI-Device Identifier: 04022495769749
• UDI-Public: 04022495769749
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K925401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 413500
• Device Lot Number: 0061618354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1