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

Catalog Number	412014
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event 1: (b)(4).The sample has not yet been received and the investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by the user facility: event 1: when the chemo pin is assembled with a 50 ml vial of paclitaxel, a 25 ml etoposide or a 16 ml docetaxel, the pin cracks and begins to leak a scant amount of chemotherapy onto the sterile hood environment.This occurs after the second or third time it is aspirated from the vial with a syringe.The nurse was wearing ppe and did not have any exposure to the scant amount of chemotherapy leaked.The environment was cleaned per facility protocol.No injuries reported.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Two (2) used chemo dispensing pins without packaging were returned for evaluation.Visual examination noted cracks in the dispensing pin's female luer lock.A pressure test was performed for leakage per specification with failing results.Therefore, the reported defect was confirmed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.Based on the results of the sample evaluation, no specific conclusions can be made regarding the cause of the reported event.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: CHEMO 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: 7523401
• Report Number: 2523676-2018-00035
• Device Sequence Number: 16500107
• Product Code: LHI
• UDI-Device Identifier: 04022495095893
• UDI-Public: 04022495095893
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K983794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 05/31/2022
• Device Catalogue Number: 412014
• Device Lot Number: 0061565101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1