MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05502-MGH

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

The physician saw the patient on post-operative day 2 and noted the epidural was leaking at the insertion site.They removed it and noted that the plastic catheter was fractured but did not sever because of the metal coil that encases the epidural tube.No portion of the catheter was retained.It is unclear when the catheter fractured during use.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter leaked during use.The customer returned one catheter piece (reference files (b)(4)).The returned catheter piece was visually examined with and without magnification.Visual examination of the returned catheter revealed the likely most distal side of the catheter was returned as the distal tip appears to be intact and the likely most proximal end appears to be missing.At the point of separation, neither the extrusion nor the coils appear to be stretched.Damage of the coils and extrusion can be seen at approximately 121mm from the distal end.A cut can also be seen in the extrusion at the same location reference files (b)(4)).No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler (c05158).The returned catheter extrusion piece measures approximately 19.7cm.The extrusion does not appear to be stretched at the point of separation.At least other remarks: 68.8cm of the catheter is missing as the specification for the epidural catheter indicates that the proper length of an epidural catheter is 88.5-91.5 cm per graphic kz-05400-002 rev.8.Specifications per graphic kz-05400-002; rev.08 were reviewed as a part of this complaint investigation.The ifu for this product, e-17019-100b rev.07, was reviewed as a part of this complaint investigation.The ifu for this product warns the user "do not alter the catheter or any other kit/set component during insertion, use, or removal (except as instructed)." the ifu also contains catheter removal instructions with a list of warnings including, "never tug or quickly pull on catheter during removal from patient to reduce risk of breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position." the ifu also provides alternate catheter removal techniques if difficulty is encountered and indicates "since any epidural catheter can inadvertently be separated if excessive force is applied during removal, clinicians must be aware of the importance of proper removal technique." a corrective action is not required at this time as the condition of the sample received indicates operational context caused or contributed to this event.The reported complaint of the catheter leaking was confirmed based upon the condition of the sample received.Although, no functional testing for leaking could not be performed, visual examination revealed the extrusion of the returned catheter piece was damaged and a cut could be seen.The catheter was received missing the proximal end.At the point of separation, the extrusion showed no signs of stretching.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.The ifu for this product also indicates not to alter the catheter in anyway.Therefore, based upon the condition of the sample received and the observed evidence of damage to the extrusion, operational context caused or contributed to this event.

Event Description

The physician saw the patient on post-operative day 2 and noted the epidural was leaking at the insertion site.They removed it and noted that the plastic catheter was fractured but did not sever because of the metal coil that encases the epidural tube.No portion of the catheter was retained.It is unclear when the catheter fractured during use.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6544987
• MDR Text Key: 74490709
• Report Number: 1036844-2017-00182
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: ASK-05502-MGH
• Device Lot Number: 23F16H1048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 77