MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number ASK-05500-NRON

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

The catheter got torn before use on a patient.Therefore, a new kit was opened instead.

Manufacturer Narrative

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

Manufacturer Narrative

Qn#(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73f2100973 was manufactured on 06/29/2021 a total of (b)(4) pieces.Lot was released on 07/08/2021.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.One half of a clip was also returned loose.The loose clip was the hook half and had a staggered break at the hinge (outer hinge broken in half and inner hinge broken on pierced boss side).The cartridge was visually examined with and without magnification.The cartridge was returned with 2 intact clips and half of a broken clip remaining in it.The extra half of a clip was the pierced boss half of the broken clip that was returned loose.The returned sample appears used as there is biological material present on the device.The fingers in the clip slot on the cartridge where the broken clip was located were damaged.The clip breaking at the hinge during loading was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.Functional inspection was performed on the two intact clips remaining in the cartridge.A lab inventory clip applier was used.Both clips were able to properly load into the applier and were successfully applied to over-stressed surgical tubing.No issues were observed with the intact clips.The ifu for this product, l02425, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." one clip was returned with a staggered break at the hinge during loading.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.The reported complaint of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.The cartridge was returned with 2 intact clips and half of a broken clip that had a staggered break at the hinge during loading.The other half of the broken clip from the cartridge was returned loose.The clip breaking at the hinge during loading was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.

Event Description

The catheter got torn before use on a patient.Therefore, a new kit was opened instead.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13507452
• MDR Text Key: 288172616
• Report Number: 3006425876-2022-00175
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2022
• Device Catalogue Number: ASK-05500-NRON
• Device Lot Number: 71F20M0384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1