MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX CONTINUOUS EPIDURAL TRAYS; PERIFIX EPIDURAL CATHETER

Model Number CE18TK

Device Problem Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

As reported by the user facility: reports the catheter sheared while trying to remove from the patient.The catheter had been in place for 8 hours and 39 minutes prior to removal.It was decided to leave the shared portion of the catheter in the patient.The patient was advised to follow-up in the er if any back or leg pain.The lot number may be 00061398259 or 0061405133 as the facility has both lots in stock, but do not know for sure which lot was used.Lot#0061405133 - mfg: 11/2014 - expiration: 05/31/2016.

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.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specific conclusions can be drawn.While no specific conclusion can be drawn, it is possible the catheter may have been withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Review of the discrepancy management system database performed for the reported lot numbers did not reveal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 th reported catalog number or catheter material number.There were no other reports of this nature against the reported lot numbers.All available information has been forwarded to the device manufacturer of the catheter.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL TRAYS
• Type of Device: PERIFIX EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4480177
• MDR Text Key: 19800897
• Report Number: 2523676-2015-00014
• 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 Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: CE18TK
• Device Catalogue Number: 332220
• Device Lot Number: 0061398259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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