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 Patient Involvement (2645)
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.It should be noted that the end user has two (2) possible batch numbers in stock: however, it is unsure which batch number was used.The possible batch numbers are: batch number: 0061638293, production date: 10/01/2018, expiry date: 09/30/2023, batch number: 0061627112, production date: 07/23/2018, expiry date: 06/30/2023.
Event or Problem Description
As reported by the user facility: event 1: it was reported that product dp3500 disp pin ls reflux was assembled to baxter minibag and upon inspection by pharmacist, plastic chards were found floating inside the bags.Denies any plastic floating prior to use of the dispensing pins.No injuries reported.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample.Without the actual device, a thorough investigation could not be performed.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.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or 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: 8253282
• Report Number: 2523676-2018-00119
• Device Sequence Number: 2389230
• Product Code: FPA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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 Catalogue Number: 413500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1