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

Catalog Number ASK-05502-FH1

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation report has not been submitted at this time.Teleflex will continue to monitor and trend related events.

Event Description

It was reported: the physician could not infuse through the flextip plus catheter contained in the kit.He re-seated the catheter and tried a new snaplock and was still unable to bolus through the catheter.There was no patient injury reported.

Manufacturer Narrative

(b)(4).No lot number was 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.The customer reported the catheter could not be infused.The customer returned one snaplock adapter and one epidural catheter.The components were received connected together (reference files (b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.The extrusion is discolored at approximately 11.5cm (c05158) from the proximal end of the catheter.A manual flow test was performed using the returned components.A 20ml lab inventory syringe was connected to the returned snaplock adapter and returned catheter.Using hand pressure, the water was injected.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock adapter and lab other remarks: inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating that there are no flow issues with the returned snaplock adapter.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded approximately 11.5cm (c05158) from the proximal end of the returned catheter until an occlusion was found.The wire would not thread any further.This is the same location were the discoloration was discovered.An attempt was made to thread the lab inventory wire from the distal end.The wire threaded approximately 79.8cm before an occlusion was found.The wire would not thread any further.This is also the same location where the discoloration discovered.The catheter was cut opened where the occlusion and discoloration was discovered.Microscopic examination revealed a dried crystalline material (reference files (b)(4)).A manual flow test was performed using the returned components.A 20ml lab inventory syringe was connected to the returned snaplock adapter and returned catheter.Using hand pressure, the water was injected.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock adapter and lab inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating that there are no flow issues with the returned snaplock adapter.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded approximately 11.5cm (c05158) from the proximal end of the returned catheter until an occlusion was found.The wire would not thread any further.This is the same location were the discoloration was discovered.An attempt was made to thread the lab inventory wire from the distal end.The wire threaded approximately 79.8cm before an occlusion was found.The wire would not thread any further.This is also the same location where the discoloration discovered.The catheter was cut opened where the occlusion and discoloration was discovered.Microscopic examination revealed a dried crystalline material (b)(4).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 the catheter not being able to infuse was confirmed based on the sample received.The returned epidural catheter was found to be completely occluded.Microscopic examination where the catheter was blocked indicated foreign material is present between the catheter's inner coils at approximately 11.5cm from the proximal end.An ftir analysis was performed on the material discovered in the catheter with no compound match relating to materials used to manufacture epidural catheters.No lot number was provided.A device history record review was performed based upon a lot number from sales history data with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined.

Event Description

It was reported: the physician could not infuse through the flextip plus catheter contained in the kit.He re-seated the catheter and tried a new snaplock and was still unable to bolus through the catheter.There was no patient injury reported.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCT KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6893594
• MDR Text Key: 87612390
• Report Number: 1036844-2017-00350
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-05502-FH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1