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

Catalog Number	354205
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2017
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 line was clamped and it split causing the iv set to leak blood.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical (b)(4).One (1) used set was returned for evaluation.Upon visual inspection, the tubing approx 1/2 inch above the distal caresite was blown apart, confirming the defect.It was indicated the set was used during a ct scan, most likely with a power injector.It should be noted that our primary iv sets are not rated for this procedure.Designated, labeled extension sets are recommended when performing this type of procedure.All information concerning this reported incident has been included in our trend analysis of the product line.We will maintain this report for future reference, and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: CARESITE®
• 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: 6522386
• Report Number: 9614279-2017-00042
• Device Sequence Number: 734484
• Product Code: FPA
• UDI-Device Identifier: 04046964182099
• UDI-Public: (01)04046964182099(17)191212(10)0061542914
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K790062
• 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): 03/29/2017

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: 12/12/2019
• Device Catalogue Number: 354205
• Device Lot Number: 0061542914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1