MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX® CONTINUOUS EPIDURAL TRAY; PERIFIX FX EPIDURAL CATHETER

Model Number CE17TKFC

Device Problem Break (1069)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880)

Event Date 04/14/2016

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 sample analysis or batch record review could not be performed and no specific conclusions can be drawn.While no specific conclusions can be drawn, incidents of shredded / broken catheters 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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "caution: do not withdraw catheter through needle because of the 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 after giving birth, patient complained of a headache.The patient sat up and it was observed that the patient had a wet towelette under her.When the fluid was tested with ph test, it was noted to be csf leaking.The catheter was found in the patient shredded and removed.The complete catheter was able to removed safely.The patient then had a blood patch completed with no further ill effects.

• Brand Name: PERIFIX® CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX 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: 5646475
• MDR Text Key: 44993320
• Report Number: 2523676-2016-00279
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2016

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: Health Professional
• Device Model Number: CE17TKFC
• Device Catalogue Number: 332079
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/11/2016
• 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
• Patient Outcome(s): Required Intervention