MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION COMPONENT; CATHETER, CONDUCTION, ANESTHET

Model Number IPN040153

Device Problem Failure to Advance (2524)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There was a defective tip on the arrow catheter lot 12551654.They could not thread it due to the tip.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as no valid lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, there was no record of purchase of this product by this customer.The customer reported the catheter would not thread through the epidural needle.The customer returned one epidural catheter.No epidural needle was returned.The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils.Microscopic examination of the returned catheter revealed the catheter's distal tip appears to be flattened as compared to a lab inventory catheter.No other defects or anomalies were observed.A dimensional inspection was performed on the returned epidural catheter.The outer diameter (od) of the returned catheter measured 1.05mm (caliper: (b)(4) which is within the specification of a maximum of 1.115mm per graphic kz-05400-030; rev 5.However, a definitive od measurement of the catheter's distal tip could not be accurately measured.A functional test was performed by attempting to thread the returned catheter through a lab inventory epidural needle.The returned catheter would not thread through the lab inventory needle.He returned catheter was sent to the manufacturing site (hradec) for further analysis.According to the manufacturing site, the defect is not manufacturing related.The catheters are 100% checked by a ring gauge for such defects.Specifications per graphic kz-05400-030; rev 5 was reviewed as a part of this complaint investigation.A design history review was performed for part # kz-05400-030 as a part of this complaint investigation.There have been no material changes for this part during the last two years that could have led to this complaint.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 threading through the needle was confirmed based on the sample received.The customer returned one epidural catheter.However, the epidural needle was not returned.Functional testing revealed the returned catheter would not thread through the lab inventory epidural needle's cannula.Visual examination revealed the returned catheter's distal tip appeared to be flattened.The returned sample was sent to the manufacturing site where it was revealed this type of defect would have been detected since the catheters are 100% checked by a ring gauge.The device history records were not reviewed as no valid lot number was provided by the customer and no sales history records could be found from this customer for this product.It is unknown how the catheter was handled prior to and during use.Therefore, the potential cause of this complaint could not be determined based upon the information provided and the condition of the sample received.No further action is required at this time.

Event Description

There was a defective tip on the arrow catheter lot 12551654.They could not thread it due to the tip.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: CATHETER, CONDUCTION, ANESTHET
• MDR Report Key: 12313430
• MDR Text Key: 266223889
• Report Number: 1036844-2021-00150
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902139679
• UDI-Public: 10801902139679
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

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 Model Number: IPN040153
• Device Catalogue Number: EC-05500
• Device Lot Number: 12551654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 09/22/2021
• 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