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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. PERIFIX® CONTINUOUS EPIDURAL TRAY; PERIFIX FX EPIDURAL CATHETER Back to Search Results
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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "caution: do not withdraw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.
 
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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 Key5646475
MDR Text Key44993320
Report Number2523676-2016-00279
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K813186
Number of Events Reported1
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 NumberCE17TKFC
Device Catalogue Number332079
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/19/2016
Initial Date FDA Received05/11/2016
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 Number1
Patient Outcome(s) Required Intervention;
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