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

Catalog Number SJ-05501

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

Event Type  Injury  

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

Per medwatch received: patient admitted for labor on (date redacted).Pt requested labor epidural placement on next day.Labor epidural placed by anesthesiologist on that day.Patient delivered infant on that day.Labor epidural removed by registered nurse post-delivery and epidural catheter was noted to be fragmented with the tip missing.Rn called anesthesia provider who evaluated patient, ordered radiographic images and consulted neurosurgery.Epidural catheter tip noted within left-hand side on the spinal canal extending through the ligamentum flavum region, out into the paraspinal muscles and then tapered off as if it were torn in that area, ending near the region of the fascia on the left-hand side at l4-l5 per x-ray and ct scan.Pt elected to have the broken epidural catheter tip surgically removed next day.Epidural catheter tip was evaluated by pathology and is described as tan to brown 3 cm in length portion of tubing and wire.No adherent soft tissue is noted on pat exam.The hospital has retained the catheter tip and remaining portion of epidural catheter.Photos of the catheter portions have been taken.Patient did well post-operatively, without complication and was discharged home in stable condition on post op day 1.

Event Description

Per medwatch received: patient admitted for labor on (date redacted).Pt requested labor epidural placement on next day.Labor epidural placed by anesthesiologist on that day.Patient delivered infant on that day.Labor epidural removed by registered nurse post-delivery and epidural catheter was noted to be fragmented with the tip missing.Rn called anesthesia provider who evaluated patient, ordered radiographic images and consulted neurosurgery.Epidural catheter tip noted within left-hand side on the spinal canal extending through the ligamentum flavum region, out into the paraspinal muscles and then tapered off as if it were torn in that area, ending near the region of the fascia on the left-hand side at l4-l5 per x-ray and ct scan.Pt elected to have the broken epidural catheter tip surgically removed next day.Epidural catheter tip was evaluated by pathology and is described as tan to brown 3 cm in length portion of tubing and wire.No adherent soft tissue is noted on pat exam.The hospital has retained the catheter tip and remaining portion of epidural catheter.Photos of the catheter portions have been taken.Patient did well post-operatively, without complication and was discharged home in stable condition on post op day 1.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.Visual inspection could not be performed as no sample was returned by the customer for investigation.However, the customer did provide photos that clearly show a catheter that looks to be stretched.The ifu for this kit, e-17019-100d; rev.03, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance the catheter more than 5 cm.Advancing the catheter more than 5 cm increases the likelihood of the catheter tip being placed into the anterolateral portion of the epidural space and increases the potential for the catheter knotting." the ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.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 other remarks: properly positioned in the recommended lateral neutral position." complaint verification testing could not be performed as no sample was returned for analysis.However, the reported complaint of the catheter breaking during removal was confirmed based on photos provided from the customer.Visual examination of the customer provided photos revealed a catheter that was excessively stretched.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based on the photos provided, operational context caused or contributed to this event.

• 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: 6940464
• MDR Text Key: 89230170
• Report Number: 1036844-2017-00362
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103658
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F17F0126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 81