MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 7JC1903

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The sample has not yet been received and the investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.

Event Description

As reported by the user facility: the catheter broke during use.An x-ray was taken to confirm that all pieces of the catheter were retrieved and that no follow-up procedure was required.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) used catheter and one (1) used needle were returned for evaluation.Visual examination of the returned sample showed the distal end of catheter to be broken off.The coil inside the catheter appears stretched through the needle, which indicates that the catheter was pulled.The cut of the jacket matches the geometry of the cannula's inside bevel.The visual inspection concluded that the reported defect could not have happened during the manufacturing process and could be attributed to the application.Per the instructions for use (ifu), "never pull the catheter back through the epidural needle due to the possibility of shearing or kinking the catheter.When removing the catheter, excessive force should never be applied.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for future reference and continue to monitor other reports for similar occurrences.

• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 8166569
• MDR Text Key: 130481399
• Report Number: 2523676-2018-00112
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7JC1903
• Device Lot Number: 0061613591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other