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

Catalog Number 552048

Device Problems Break (1069); Split (2537)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 05/12/2016

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 stretched and fractured at the tip end, with the inner coil unwound and extending out at the point of fracture.Stretching was also observed on the catheter tube 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.The reporting facility indicated the catheter broke outside of the patient.It is possible the catheter may have become caught on something at the patient's bedside, which stretched the catheter to the point of fracture.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or catheter material number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports a catheter was placed in an ob patient around 11am/12pm.The patient became uncomfortable around 3:30 pm.The clinician dosed the patient and it didn't relieve the pain.The clinician then noted the catheter was shredded.The catheter was split/broken outside the patient, and the spring was out.The clinician cut the catheter at the broken part and placed a new connector on the remaining end of the catheter.Around 7:30 pm the patient became uncomfortable and a nurse placed a bolus.The nurse was called back in as the patient had no relief.The nurse found that the catheter broke again right after the end piece.The piece of catheter that was left connected in the patient when the nurse placed a new connector was discarded.There was no patient injury.

• Brand Name: CUSTOM 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: 5705877
• MDR Text Key: 48006405
• Report Number: 2523676-2016-00337
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/13/2016

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 Expiration Date: 09/30/2017
• Device Catalogue Number: 552048
• Device Lot Number: 0061483904
• 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: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• 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: 35 YR