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

Catalog Number 470108-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Sepsis (2067); Septic Shock (2068)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device involved has 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: three days after the valve was inserted into the patient, an infection was observed.Furosemide was infused though the valve from (b)(6) 2020 to (b)(6) 2020.The patient experienced redness local to the insertion site, fever, and sepsis/septic shock.The customer was then treated with an iv antibiotic treatment for five days, and their condition favorably improved rapidly.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).This product was distributed in the eu only and the identified issue had no impact on product available in the u.S.Market.  a total of 2 used samples were provided for evaluation.In addition one used catheter was also provided and one photograph of a shipping label was also provided.Visual examination of the samples noted both to be defective.It was observed that the luer adapter of the distal connector was bonded to the spin lock collar.Additionally the spin lock has what appears to be signs of excess solvent are present on the male luer.Leak testing on the samples noted leakage occurring from the location where the excess solvent was observed when testing the male/female connection.No conclusions were able to be drawn from the provided photograph.Based on the evaluation of the samples the reported defect is confirmed.Based on the investigation the issue is related to the solvent bonding process during hand assembly.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, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 11280427
• MDR Text Key: 230328151
• Report Number: 2523676-2021-00027
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 470108-01
• Device Lot Number: 0061744004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization