MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION; CATHETER, CONDUCTION, ANESTHE

Catalog Number ASK-05500-BCW

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/23/2020

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

Unfortunately, we have had a large number of defective filters in the last week.To the point of significantly affective level of patient care.I have so far a tally of 13 noted incidents over a period of less than a week.They are all related to the filter but for different reasons, multiple disconnects, breakages and one that completely fell apart.It is a significant problem for us that needs to be addressed urgently.The epidural catheter was replaced in five of the cases which is reportable.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the flat filter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.

Event Description

Unfortunately, we have had a large number of defective filters in the last week.To the point of significantly affective level of patient care.I have so far a tally of 13 noted incidents over a period of less than a week.They are all related to the filter but for different reasons, multiple disconnects, breakages and one that completely fell apart.It is a significant problem for us that needs to be addressed urgently.The epidural catheter was replaced in five of the cases which is reportable.

• Brand Name: EPIDURAL CATHETERIZATION
• Type of Device: CATHETER, CONDUCTION, ANESTHE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11056459
• MDR Text Key: 223168078
• Report Number: 1036844-2020-00334
• 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: foreign,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 Expiration Date: 08/31/2022
• Device Catalogue Number: ASK-05500-BCW
• Device Lot Number: 13F20H0798
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1