MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. CUSTOMER COMBINED SPINAL/EPIDURAL TRAY; EPIDURAL CATHETER

Catalog Number 530122

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

As reported by the user facility: reports patient had an epidural placed for child birth.The clinician placed the needle and catheter, and over-threaded it.When withdrawing the catheter back, it sheared leaving approximately 11 cm in the patient.The patient has not had the sheared catheter piece removed at this time.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report # (b)(4).The actual device involved in the reported incident was not returned for evaluation.However, the facility returned an unused, unopened tray, identifying the reported lot number (0061380535), for evaluation.The catheter from the tray was subjected to occlusion, leakage, and tensile strength testing according to our specification with acceptable results.The event description did indicate the catheter was over-threaded.Without the actual sample, a thorough evaluation could not be performed and no specific conclusions can be drawn.While no specific conclusion can be drawn, incidents of this nature can occur when a catheter becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Review of the discrepancy management system database performed for the reported lot number did not reveal any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.

• Brand Name: CUSTOMER COMBINED SPINAL/EPIDURAL TRAY
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109-9341 ; 6102660500
• MDR Report Key: 4576711
• MDR Text Key: 22268068
• Report Number: 2523676-2015-00051
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 530122
• Device Lot Number: 0061380535
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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