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

Catalog Number	354220
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
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: event 3: tubing separating from distal y-site during infusion of solution.Veterinary technicians noticed that the tubing that connects into the housing of the distal y-site was separating just by pulling lightly.The staff came back to a patient and noticed the set had separated even without manual manipulation.This has happened on 5 occasions now, but the sets have been thrown out.The staff were checking the strength of each set before attaching to a patient to avoid any issues.It appears the set has been exposed to some blood from an animal.No injury reported.
Additional Manufacturer Narrative
Event 3: this report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.The returned sample was tested for leakage per specification with passing results.All bonded joints on the set were also pull tested per specification with passing results.The defect of disconnection of a bonded joint was not confirmed.Review of the discrepancy management system database was unable to be performed because the lot number was reported as unknown.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• 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: 7683825
• Report Number: 9614279-2018-00112
• Device Sequence Number: 13802374
• Product Code: FPA
• UDI-Device Identifier: 04046964182358
• UDI-Public: 04046964182358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 354220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1