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

Catalog Number	470005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).No samples were returned for evaluation in connection with this incident and no lot number was provided.Without the actual device or lot number, a thorough investigation could not be performed.However, on tuesday, (b)(6) 2018, a conference call was held with dr.(b)(6) and (b)(6) to discuss issues with the iv sets.B.Braun representatives explained the importance of tightening the joints prior to use, and dr.(b)(6) indicated that he understood the need for tightening the joints and that he would make sure the clinicians were re-educated regarding this matter.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample, lot number, and/or any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
Event 2: as reported by the user facility: about 12-15 sets have come apart during surgery causing blood leakage.

• 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: 8232880
• Report Number: 9614279-2018-00217
• Device Sequence Number: 19310432
• Product Code: FPA
• UDI-Device Identifier: 04046964297199
• UDI-Public: 04046964297199
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 01/09/2019

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: 470005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1