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

Catalog Number ASK-17019-SM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

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

The reported states: this issue involves the new filter that was placed in the ask epidural kits without the customer being made aware.The new filter with rotating collar is not clinically acceptable and the collar twists completely off the filter.Severe incidents have occurred where the filter becomes dislodged and the catheter is exposed and contaminated.Sometimes this leads to switching out the epidural.The customer is requesting these filters be replaced immediately.Additional information indicates that one(1) patient had the epidural catheter removed and replaced.Other filters fell off the catheter and needed to be secured with tape.The patient's condition is fine and no antibiotic therapy was required.

Event Description

The reported states: this issue involves the new filter that was placed in the ask epidural kits without the customer being made aware.The new filter with rotating collar is not clinically acceptable and the collar twists completely off the filter.Severe incidents have occurred where the filter becomes dislodged and the catheter is exposed and contaminated.Sometimes this leads to switching out the epidural.The customer is requesting these filters be replaced immediately.Additional information indicates that one(1) patient had the epidural catheter removed and replaced.Other filters fell off the catheter and needed to be secured with tape.The patient's condition is fine and no antibiotic terapy was required.

Manufacturer Narrative

(b)(4).A device history record review was performed on the flat filter and epidural catheter with no relevant findings.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 without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the flat filter and epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the filter having issues could not be determined based upon the information provided and without the sample.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9244360
• MDR Text Key: 175089748
• Report Number: 1036844-2019-01009
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-17019-SM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1