MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA; CATHETER, CONDUCTION, ANESTHET

Catalog Number ASK-17019-AG

Device Problem Obstruction of Flow (2423)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported issue: we have had a few catheters that were not patent (not allowing flow of medication) and had to be replaced.I have kept a few of them along with their lot numbers.The patients were fine, except for the second procedure.I do not think any of them came back with pdph.Four that i know of i have heard rumors of a few others but i never saw an rl6 or got confirmation from the performing provider.We replaced the catheters with working catheters.Since then we usually check the catheter prior to placement but this is inconsistent.The lot numbers on the two i kept are both 23f20g0141.Unfortunately, i do not have the lot numbers for the rest.

Manufacturer Narrative

Qn#(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.

Event Description

Reported issue: we have had a few catheters that were not patent (not allowing flow of medication) and had to be replaced.I have kept a few of them along with their lot numbers.The patients were fine, except for the second procedure.I do not think any of them came back with pdph.Four that i know of i have heard rumors of a few others but i never saw an rl6 or got confirmation from the performing provider.We replaced the catheters with working catheters.Since then we usually check the catheter prior to placement but this is inconsistent.The lot numbers on the two i kept are both 23f20g0141.Unfortunately, i do not have the lot numbers for the rest.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• Type of Device: CATHETER, CONDUCTION, ANESTHET
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11067251
• MDR Text Key: 247266300
• Report Number: 1036844-2020-00339
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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 Catalogue Number: ASK-17019-AG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1