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

Catalog Number AK-05502

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that there was difficulty threading the needle through the catheter and this resulted in a wet tap.The patient's condition was reported as fine.

Event Description

It was reported that there was difficulty threading the needle through the catheter and this resulted in a wet tap.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural needle and epidural catheter with no relevant findings.The customer reported the catheter would not thread through the epidural needle.The customer returned one epidural catheter.The customer also returned two epidural needles (reference attached files (b)(4)).The components were visually examined with and without magnification.Visual examination of the returned needles revealed that both needles appear typical.The each returned needle's bevel appears polished and smooth with no observed burrs.Both returned needle's cannula appears typical.No defects or anomalies were observed.Visual examination of the returned catheter revealed that the catheter appears used.Biological material can be seen between the inner coils.Also, damage can be seen at approximately 22.8cm, 26cm, and 28.9cm from the distal end.At 26cm (c05158) from the distal end, the coils appear to be flattened (reference files (b)(4)).No other defects or anomalies were observed.A dimensional inspection was performed on the returned epidural needles.Inner diameter (id) measurement of the returned needles revealed a value of 0.046" (1.17mm) using pin gauges (c05157), which is within specification of 1.17mm per graphic kz-05500-007; rev 9.A dimensional inspection was performed on the returned epidural.The outer diameter (od) of the returned catheter measured 1.05mm (caliper c05155) which is within the specification of a maximum of 1.115mm per graphic kz-05400-002; rev 9.A functional test was performed by attempting to thread the returned catheter through the returned epidural needles.The catheter was thread at the distal end and would thread through the first epidural needle with no resistance met until the damaged part of the catheter reached the cannula where some resistance was met.After the damaged part of the catheter passed through, the remaining catheter passes through the needle with no resistance met.The catheter was thread at the distal tip for the second returned needle with the same result.A lab inventory catheter was thread at the distal end of the returned needles and would thread through both epidural needles with no resistance met.A drag test was performed per pip-013 using the returned components and a weight (c05406).The catheter could thread through the returned needles with no resistance met except where the catheter was damaged.Specifications per graphic kz-05500-007, rev 9 and kz-005400-002; rev 9 were reviewed as a part of this complaint investigation.A design history review was performed for part # kz-05500-007 and kz-005400-002 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.Therefore, based on the condition of the sample received and the time of discovery indicate operational context caused or contributed to this event.

Event Description

It was reported that there was difficulty threading the needle through the catheter and this resulted in a wet tap.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural needle and epidural catheter with no relevant findings.The customer reported the catheter would not thread through the epidural needle.The customer returned one epidural catheter.The customer also returned two epidural needles (reference attached files (b)(4)).The components were visually examined with and without magnification.Visual examination of the returned needles revealed that both needles appear typical.The each returned needle's bevel appears polished and smooth with no observed burrs.Both returned needle's cannula appears typical.No defects or anomalies were observed.Visual examination of the returned catheter revealed that the catheter appears used.Biological material can be seen between the inner coils.Also, damage can be seen at approximately 22.8cm, 26cm, and 28.9cm from the distal end.At 26cm (c05158) from the distal end, the coils appear to be flattened (reference files (b)(4)).No other defects or anomalies were observed.A dimensional inspection was performed on the returned epidural needles.Inner diameter (id) measurement of the returned needles revealed a value of 0.046" (1.17mm) using pin gauges (c05157), which is within specification of 1.17mm per graphic kz-05500-007; rev 9.A dimensional inspection was performed on the returned epidural.The outer diameter (od) of the returned catheter measured 1.05mm (caliper c05155) which is within the specification of a maximum of 1.115mm per graphic kz-05400-002; rev 9.A functional test was performed by attempting to thread the returned catheter through the returned epidural needles.The catheter was thread at the distal end and would thread through the first epidural needle with no resistance met until the damaged part of the catheter reached the cannula where some resistance was met.After the damaged part of the catheter passed through, the remaining catheter passes through the needle with no resistance met.The catheter was thread at the distal tip for the second returned needle with the same result.A lab inventory catheter was thread at the distal end of the returned needles and would thread through both epidural needles with no resistance met.A drag test was performed per pip-013 using the returned components and a weight (c05406).The catheter could thread through the returned needles with no resistance met except where the catheter was damaged.Specifications per graphic kz-05500-007, rev 9 and kz-005400-002; rev 9 were reviewed as a part of this complaint investigation.A design history review was performed for part # kz-05500-007 and kz-005400-002 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.Therefore, based on the condition of the sample received and the time of discovery indicate operational context caused or contributed to this event.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7571232
• MDR Text Key: 110338347
• Report Number: 1036844-2018-00149
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F17M0159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1