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

Catalog Number	354207
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
(b)(4).The device involved 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: event 1: customer reports that the filter leaked.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used set with packaging was returned for evaluation.Visual examination of the set noted no visual defects.The set was leakage tested per specification with passing results.In order to replicate the event, the set was connected to a water source at 1 psi.Water was noted to come out of the proximal hole in the filter.No other issues were noted.All available information was forwarded to the supplier.Per the supplier, these circumstances were very difficult to replicate and it is highly unlikely there were many other occurrences of this nature prior to the changes made.There was a brief 100% inspection process put in place followed by a qa sample release inspection to reject any defects found.The qa release inspection had passing results.Since these lots were manufactured prior to any corrections, no further corrective action will be taken at this time.All available information regarding this occurrence has been forwarded to our material review broad (mrb) business unit leaders and all personnel involved in the manufacturing and inspection of this product in order to heighten awareness.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: 8484491
• Report Number: 9614279-2019-00038
• Device Sequence Number: 2015099
• Product Code: FPA
• UDI-Device Identifier: 04046964182136
• UDI-Public: 04046964182136
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• 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): 07/23/2019

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: 06/30/2021
• Device Catalogue Number: 354207
• Device Lot Number: 0061629371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1