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

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.

• Brand Name: PORTEX EPIDURAL MINIPACK
• Type of Device: ANESTHESIA 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 Key: 5420070
• MDR Text Key: 37798444
• Report Number: 2183502-2016-00154
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• 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 Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 100/391/116
• Device Catalogue Number: 100/391/116
• Device Lot Number: 2789130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other