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

Catalog Number	470195
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Two (2) used samples were returned in conjunction with this complaint.Both sets were noted to be attached to several other manufactures devices such as onguard adaptors and carefusion syringe sets.Both returned samples were functionally tested for leakage per specification with failing results.The samples were found to be leaking from the distal caresite valves evaluated part (b)(4).One caresite leakage was due to a lack in the threads of the port.The second caresite leakage was due to damage to the piston of the valve.Although the defect of leakage was confirmed on both caresite valves, since the sets were used in conjunction with several other manufactures devices, the exact root cause of the crack and damage to the piston was not able to be determined at this time.However, the defect does not appear to be related to any b.Braun manufacturing processes for the valves.We will maintain this report for further references and continue to monitor other reports for similar occurrences.
Event or Problem Description
As reported by the user facility: event 1: tubing leaking during chemotherapy.Nurse was running methotrexate on pediatric oncology floor and set (b)(4) was observed to be leaking.

• Brand Name: EXTENSION 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: 6648898
• Report Number: 9614279-2017-00049
• Device Sequence Number: 13715461
• Product Code: FPA
• UDI-Device Identifier: 04046964823428
• UDI-Public: 04046964823428
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K153293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

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: 09/27/2019
• Device Catalogue Number: 470195
• Device Lot Number: 0061531799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR