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

Model Number 415122

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Bacterial Infection (1735); Fever (1858)

Event Date 07/17/2020

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: it was reported that several patients with the caresite connected to them have been running a fever.When blood culture was performed, resident skin bacteria was detected.It is suspected that those bacteria may have been mixed-in from the "shrunk valve".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Two (2) boxes of unopened caresite valves containing approximately 182 pcs were provided for evaluation.60 of the returned samples were subjected to extensive etr testing under various conditions.The pistons were extracted from the tested samples and evaluated by engineering with passing results.House retain samples were also tested per internal specification and found acceptable.In addition the samples were accessed multiple times and dissected in order to evaluate the silicone piston.The silicone piston was found acceptable with no damage noted.In addition 4 sets of retain samples that contained the same piston lots were evaluated and found to be within specification.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
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10451370
• MDR Text Key: 204352158
• Report Number: 2523676-2020-00248
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964115998
• UDI-Public: 04046964115998
• Combination Product (y/n): N
• PMA/PMN Number: K140311
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 415122
• Device Catalogue Number: 415122
• Device Lot Number: 0061722283
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other