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

Catalog Number	470103
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not 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: it was reported that the product leaked blood.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample was returned for evaluation.The returned extension set was connected to a 3ml syringe.The removable caresite was not returned with the set.Visual examination of the returned sample noted no visual defects.The set was tested for leakage, and leakage was found at the female luer.Closer examination of the set revealed a vertical crack on the green luer.Therefore, the reported defect was confirmed.No other defects were noted.The exact root cause could not be determined at this time.However, incidents of cracked leaking valves can be caused by several factors, including but not limited to the product being subjected to aggressive solvents/drugs, excessive mechanical stresses (over-tightening), or other various unforeseen circumstances during the clinical application.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non- conformances were noted during the in process or final product inspection.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: 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: 8320125
• Report Number: 9614279-2019-00013
• Device Sequence Number: 16523134
• Product Code: FPA
• UDI-Device Identifier: 04046964298592
• UDI-Public: 04046964298592
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083723
• 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): 03/22/2019

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 470103
• Device Lot Number: 0061568011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1