MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE; SET, ADMINISTRATION, INTRA

Model Number 470108

Device Problem Fluid/Blood Leak (1250)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

As reported by the user facility: during the first 15 minutes of the blood transfusion, no abnormalities were noted.However, 30 minutes later, the product leaked.Blood was observed at the anti-reflux valve.The transfusion was stopped, the device was changed, and the transfusion was resumed without issues.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.Visual examination of the sample noted that a luer connector was broken off inside the caresite valve.Based on the evaluation of the sample the reported defect is confirmed.Although the exact root cause cannot be determined, previous engineering testing cited a probable root cause could be alcohol exposure of certain male adapters, which can lead to difficulty removing or breakage of male luer tapers when connected to female luers.Per the ifu, "swab top lad vigorously for 15 seconds with 70% isopropyl alcohol and allow to air dry prior to use." please note the air drying of the alcohol prior to use.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
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9699370
• MDR Text Key: 180418656
• Report Number: 2523676-2020-00036
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964093753
• UDI-Public: 04046964093753
• Combination Product (y/n): N
• PMA/PMN Number: K942988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470108
• Device Catalogue Number: 470108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1