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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. PORTEX EPIDURAL MINIPACK ANESTHESIA KIT

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SMITHS MEDICAL ASD INC. PORTEX EPIDURAL MINIPACK ANESTHESIA KIT Back to Search Results
Model Number 100/391/116
Device Problems Detachment Of Device Component (1104); Fracture (1260)
Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446); Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
User facility reported the device was placed in use with patient in late (b)(6) 2015 during a laparotomy. According to reporter, several days later the catheter was removed from patient. Two months following catheter removal, during a re-dress of the surgical wound, a portion of the catheter was found protruding from patient. The catheter fragment was removed. It was reported that the patient had infections post-surgery and was remitted in october for a wound infection and dehiscence following his original laparotomy. During this hospital stay he was given a wound washout and exploration. Stitches were removed and wound packed without further issue. No permanent adverse effects reported.
 
Manufacturer Narrative
The manufacturing facility performed a device history review of the lot number reported (2789130): the review showed no deviations or abnormalities related to the reported issue. No device sample has been made available for evaluation in this case. The investigation was routed to manufacturing facility with no product sample. The user facility provided a photograph of the complaint device. The photograph showed a catheter length with a broken end. The broken end of the catheter had a smooth surface like a cut with a blunt edge. The manufacturing facility performed device testing on a sample catheter in effort to duplicate the physical characteristics as shown in the complaint sample photograph. The manufacturing facility was able to induce similar damage (catheter break with smooth blunt edge) by pulling the catheter through a touhy needle at a 90 degree angle (a touhy needle is included with the portex epidural minipack). The device instructions include the following warning: "never pull back the catheter through the epidural tuohy needle as this can result in the catheter being cut and left in the epidural space. If catheter insertion difficulties are encountered, the epidural tuohy needle and catheter should be removed carefully together as a single unit, and the procedure repeated. " the issue was determined most likely caused by damage induced during use.
 
Manufacturer Narrative
Correction to final manufacturing medical device report. Please see correction to the manufacturing address. The manufacturing facility performed a device history review of the lot number reported (2789130): the review showed no deviations or abnormalities related to the reported issue. No device sample has been made available for evaluation in this case. The investigation was routed to manufacturing facility with no product sample. The user facility provided a photograph of the complaint device. The photograph showed a catheter length with a broken end. The broken end of the catheter had a smooth surface like a cut with a blunt edge. The manufacturing facility performed device testing on a sample catheter in effort to duplicate the physical characteristics as shown in the complaint sample photograph. The manufacturing facility was able to induce similar damage (catheter break with smooth blunt edge) by pulling the catheter through a tuohy needle at a 90 degree angle (a tuohy needle is included with the portex epidural minipack). The device instructions include the following warning: "never pull back the catheter through the epidural tuohy needle as this can result in the catheter being cut and left in the epidural space. If catheter insertion difficulties are encountered, the epidural tuohy needle and catheter should be removed carefully together as a single unit, and the procedure repeated. " the issue was determined most likely caused by damage induced during use.
 
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Brand NamePORTEX EPIDURAL MINIPACK
Type of DeviceANESTHESIA KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
10 bowman drive
keene NH 03431
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.,
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
michele seliga
1265 grey fox rd.
st. paul, MN 55112
7633833052
MDR Report Key5420070
MDR Text Key37798444
Report Number2183502-2016-00154
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2019
Device Model Number100/391/116
Device Catalogue Number100/391/116
Device Lot Number2789130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/09/2016 Patient Sequence Number: 1
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