MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC 20G SPIROL; CATHETER

Model Number A-EP-098

Device Problems Mechanical Problem (1384); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

Reported to epimed by (b)(6) on august 28, 2018: "anesthesiologist at (b)(6) hospital (b)(6) was performing a tap block yesterday and when he tried to remove the stylet from the tbloc catheter, he could not pull back the stylet and had to perform the procedure again with a new tray." additional information regarding event reported to epimed by (b)(6) on september 13, 2018 per epimed inquiry: "the catheter was sheared when the physician attempted to remove the needle.As he pulled the needle out and met resistance the catheter sheared." upon return to epimed, both devices were examined.The accompanying finishing stylet was returned to epimed outside of the returned catheter.During examination, it was observed that the accompanying stylet was severely twisted.This twisting was in a coil-like shape.The returned catheter coating was sheared approximately 7" from the catheter's distal end.The catheter's internal spring remained fully intact.The damage to the catheter was indicative of the device being pulled apart as it was jagged in shape and not cut clean as would be expected if the device were cut by a sharp object; i.E.Needle tip.Measurement testing was conducted and it was determined that none of the catheter coating was missing from the device.In order to acquire additional information regarding the reported event, epimed emailed (b)(6) on september 14, 2018 with the following questions: any info on the needle? did the end-user manipulate the catheter in any way while the stylet was in place? did the end-user experience resistance removing both the needle and catheter as a unit or was the needle removed while catheter was still in place? did the end-user experience any resistance while attempting to remove the catheter? did the end-user attempt to remove the needle while the stylet was in place? as of the date of this report, halyard has not responded to this inquiry.Due to the nature of the reported complaint, tensile testing was performed using the ce-021 (tensile tester - tinius olsen).The tensile test was performed using the returned 20g spirol catheter.The tensile test was completed, yielding a result of 4.29 lbf, exceeding the minimum standard of 3.37lbf per bs 6196:1989.The damage to both the catheter and stylet is indicative of the styletted catheter possibly becoming snagged on an internal structure and subsequently being pulled with force to remove from the patient.The damage to the stylet suggests that the styletted catheter may have been wrapped around the end-users finger or another object while tension was being applied to the styletted catheter.Complaint history was reviewed; revealing this is the first time a stylet has been returned to epimed in the condition that was observed with this stylet.If additional information becomes available regarding this reported complaint, epimed will update the mdr.

Event Description

Reported to epimed by (b)(6) on august 28, 2018: "anesthesiologist at (b)(6) hospital (b)(6) was performing a tap block yesterday and when he tried to remove the stylet from the tbloc catheter, he could not pull back the stylet and had to perform the procedure again with a new tray." additional information regarding event reported to epimed by (b)(6) on september 13, 2018: "the catheter was sheared when the physician attempted to remove the needle.As he pulled the needle out and met resistance the catheter sheared.".

• Brand Name: 20G SPIROL
• Type of Device: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: kris knapp ; 141 sal landrio drive; johnstown, NY 12095
• MDR Report Key: 7915495
• MDR Text Key: 123374291
• Report Number: 1316297-2018-00010
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2018

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?: No
• Device Operator: No Information
• Device Model Number: A-EP-098
• Device Catalogue Number: 70148607
• Device Lot Number: NO LOT PROVIDED.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other