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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 CE17TKFCPS
Device Problems Coiled (1098); Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn. The event description did indicate that there was some difficulty with the insertion, and resistance was met when attempting to remove the catheter. 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. 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.
 
Event Description
As reported through medwatch # mw5062698: "crna attempted to insert epidural catheter, unable to advance far enough in. Attempted to remove catheter, after 1 inch had been pulled out, resistance was met. Despite repositioning of patient, turning bevel of needle and removing the needle, the catheter would not come out. After the needle was removed, tension was applied to the catheter and a coiled strand was removed. It did not appear as if the catheter was still completely intact. The catheter was measured against a new catheter and it is approx. 3/4 inch shorter. A (b)(6) year old gravida 2 female admitted with decreased fetal movement and found with no amniotic fluid (bbp 6 of 8). Labor was induced using cervidil and pitocin. A second epidural catheter was inserted 2 levels above without difficulty. After delivery, the second epidural catheter was removed without difficulty. " during a follow-up phone call with the reporting facility, the reporter stated that a ct scan performed did not show anything in the patient. The facility will not release the sample of the catheter at this time.
 
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Brand NamePERIFIX® CONTINUOUS EPIDURAL TRAY
Type of DevicePERIFIX 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 Key5808143
MDR Text Key50839472
Report Number2523676-2016-00479
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 health professional,other,use
Reporter Occupation
Type of Report Initial
Report Date 06/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Model NumberCE17TKFCPS
Device Catalogue Number332078
Device Lot Number0061476648
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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