MAUDE Adverse Event Report: CARESITE®; SET, ADMINISTRATION, INTRA

Model Number 354205

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).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: "the fluid fill chamber appeared to have contaminants in it." no injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One photograph of an iv set was provided for evaluation.Visual examination of the photograph notes degraded material present between the drip chamber and the spike.Based on the supplier's response, an extra round of cleaning of the cylinder, nozzle, and screw of the molding machine are currently being implemented.Retained units were evaluated and passed the internal testing.A 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.In addition, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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
• MDR Report Key: 12157457
• MDR Text Key: 261486124
• Report Number: 2523676-2021-00207
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964182099
• UDI-Public: 04046964182099
• Combination Product (y/n): N
• PMA/PMN Number: K083723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 08/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 354205
• Device Catalogue Number: 354205
• Device Lot Number: 0061768446
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1