MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EPIDURAL ANESTHESIA TRAY; FX EPIDURAL CATHETER

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report # (b)(4).One used catheter fragment, without packaging, was received for evaluation.The catheter appeared fractured at the tip end, with the inner coil unwound and extending out at the point of fracture.There was significant stretching/elongation observed along the catheter tube and at the area of the fracture.The damage observed on the catheter appears consistent with catheters in which a section is pulled beyond its design capabilities.While no specific conclusion can be drawn, the catheter was most likely caught up on something while an excess force was being applied to cause the amount of stretching that was observed.Without the lot number, a batch record review could not be performed.No adverse quality trends of this nature were identified during the complaint review process for the involved catheter material.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports a broken catheter.Per follow-up correspondence with the reporting facility, the reporter indicated the event occurred in (b)(6) 2015 but was not reported to b.Braun at the time.A second incident of a broken catheter recently occurred, and the reporter realized she still had this catheter from (b)(6) 2015.The reporter stated this was the first time they had an issue with a catheter breaking.The reporter remembers the patient being uncomfortable and it was discovered that the catheter was broken.The reporter does not remember if the catheter was replaced or if catheter was cut and a new catheter connector placed on the catheter.There was no patient injury and no part of the catheter was left in the patient.The reporter sent this catheter back to b.Braun unannounced, along with the catheter from the second incident.The second incident was filed under report # 2523676-2016-00337.

• Brand Name: EPIDURAL ANESTHESIA TRAY
• Type of Device: FX EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5705885
• MDR Text Key: 48009137
• Report Number: 2523676-2016-00338
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 28 YR