MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 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 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A crack was found on the female connector of the flat filter during use on a patient.Therefore, the catheter was removed and replaced with a new kit.

Event Description

A crack was found on the female connector of the flat filter during use on a patient.Therefore, the catheter was removed and replaced with a new kit.

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was opened for lot # 71p20k0006, based on a design change that was not released before updated material was utilized.Not relevant to this complaint.The customer reported a crack was found on the filter during use.The customer returned one flat filter nrfit.The returned filter was visually examined with and without magnification.Visual inspection of the returned filter revealed the filter has a crack on the female connector end.The filter is also used as the filter membrane has a yellowish tint.No other defects or anomalies were observed.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of a crack was found on the filter during use was confirmed based on the sample received.Visual examination of the returned filter revealed a crack at the female connector end.A device history record review was performed on the flat filter with no findings relevant to this complaint issue.It is unknown how the filter was handled prior to and during use or pressure used.Therefore, the potential cause of this complaint could not be determined.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12779100
• MDR Text Key: 281394282
• Report Number: 3006425876-2021-01035
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2022
• Device Catalogue Number: ASK-05500-NRON
• Device Lot Number: 71F20L1272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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