MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CUSTOM SPINAL/EPIDURAL TRAY; SPRINGWOUND 19 GA. FX EPIDURAL CATHETER

Catalog Number 332238

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn.While no specific conclusions 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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through needle due to possible danger of shearing." no adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved catheter material number.If additional pertinent information becomes available or if the physical sample is received for evaluation, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the doctor placed a catheter in the patient for a total hip replacement (2 hour surgery).When the doctor went to remove the catheter, the catheter broke off inside the patient, and had to be surgically removed.There were no ill effects to the patient.The length of catheter that broke off in the patient is unknown.

Manufacturer Narrative

Medwatch # mw5057156 was received for this occurrence, in which the involved lot number was reported and verified by the reporting facility.The actual device involved in the reported incident was not returned for evaluation.However, the house retain samples of the involved lot # 0061384705 were pulled for evaluation.The catheters from the retain kits were subjected to occlusion, leakage, and tensile strength testing according to our specification with acceptable results.The epidural needles from the retain kits were also subjected to a skiving functional test according to our specification with acceptable results.There was no cutting or skiving of the catheters observed.Review of the discrepancy management system database performed for the involved lot number did not reveal any abnormalities or nonconformances of this nature.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: CUSTOM SPINAL/EPIDURAL TRAY
• Type of Device: SPRINGWOUND 19 GA. 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: 5195281
• MDR Text Key: 30141738
• Report Number: 2523676-2015-00505
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2015

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: Physician
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 332238
• Device Lot Number: 0061384705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2014
• 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
• Patient Outcome(s): Required Intervention