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

Catalog Number	354203
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
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: after injecting through one of the claves, the internal part of the clave didn't close off, so fluid flowed freely out of it.This is a high level concern for us because we inject radioactive solution into the iv tubing, and if the clave stays open, radioactivity spills out and contaminates the patient and area.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Thirty three (33) unopened samples identifying lot # 006167205 were returned for evaluation.Fifteen (15) random samples were selected and tested for occlusion and leakage per specification with passing results.In addition all caresite injunction sites were functionally tested with a syringe and all valves functioned properly with no leakage observed.Random samples of the returned product were tested per specification with passing results.The reported defect of the caresite injection site "not closing off" was not able to be replicated or confirmed.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 DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 8850446
• Report Number: 9614279-2019-00115
• Device Sequence Number: 16215786
• Product Code: FPA
• UDI-Device Identifier: 04046964182051
• UDI-Public: 04046964182051
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 08/29/2019

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: 03/31/2022
• Device Catalogue Number: 354203
• Device Lot Number: 0061672505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1