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

Catalog Number HS-05501

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received via medwatch 5094868.No customer contact information provided created complaint using complaint's generic acct#.Patient undergoing right total hip arthroplasty.At end of procedure, staff removed spinal epidural catheter and noticed that black tip was not visible.Patient underwent ct scan, catheter tip noted at l4-l5.Patient returned to operating room on (b)(6) 2020 for removal of catheter tip.Staff reported no unusual resistance when pulling catheter during initial procedure.

Manufacturer Narrative

Qn#(b)(4).A device history record review could not be performed as no lot number was provided by the customer.The ifu for this kit, e-17019-109a; rev.07, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." the ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." 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.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.

Event Description

Received via medwatch(b)(4).No customer contact information provided created complaint using complaint's generic acct#.Patient undergoing right total hip arthroplasty.At end of procedure, staff removed spinal epidural catheter and noticed that black tip was not visible.Patient underwent ct scan, catheter tip noted at l4-l5.Patient returned to operating room on (b)(6)2020 for removal of catheter tip.Staff reported no unusual resistance when pulling catheter during initial procedure.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10358396
• MDR Text Key: 202514083
• Report Number: 1036844-2020-00209
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HS-05501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention