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

Catalog Number	490067
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: the first nurse disconnected the iv administration set after continuous iv fluids infusion from the caresite valve extension set earlier in the shift.When the next shift nurse went to reconnect iv administration set to caresite valve extension set she said it was difficult to reconnect it, so therefore she connected the luer ending to the caresite valve tighter.Later in the shift, the nurse went to disconnect the iv administration set after infusion, and the luer ending of the iv administration set broke off into the caresite valve.As a result, the valve was forced open and the patients' blood started to leak out of the valve.The nurse immediately had to discontinue the iv completely, removing the iv catheter completely, to prevent further bleeding.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used distal portion of the primary set, along with the caresite extension set (without packaging) were returned for evaluation.Upon visual inspection it was noted that the distal male luer of the primary set was broken off in the port of the caresite valve of the extension set.The defect of a distal connector broken off in the caresite valve of the extension set was visually confirmed.Although the reported defect was confirmed, the exact root cause was unable to be determined at this time.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: IV ADMINISTRATION 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: 7837114
• Report Number: 9614279-2018-00142
• Device Sequence Number: 16441198
• Product Code: FPA
• UDI-Device Identifier: 04046964186042
• UDI-Public: 04046964186042
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/28/2018

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 Catalogue Number: 490067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1