MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED

Model Number IPN917235

Device Problems Leak/Splash (1354); Material Rupture (1546)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Reported as "it was defective".It was reported that during use on a patient, the catheter blew a puncture hole at 500 psi and max is supposed to be 540 psi.As a result, another catheter was used.No medical intervention was needed.No report of patient harm or injury.Multiple inquiries regarding the insertion site of the second catheter were not answered by the customer.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Reported as "it was defective".It was reported that during use on a patient, the catheter blew a puncture hole at 500 psi and max is supposed to be 540 psi.As a result, another catheter was used.No medical intervention was needed.No report of patient harm or injury.Multiple inquiries regarding the insertion site of the second catheter were not answered by the customer.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).No lot number was reported.The lot number on the returned original packaging pouch/label is 16f22l0045.Returned for investigation was a 5fr.80cm berman catheter with the original packaging pouch.The sample was returned in a cardboard box and was in a sealed bio-hazard bag.Upon return, the catheter body was immediately noted damaged near the junction hub at approximately 89.6cm from the distal tip of the catheter.Under microscopic inspection, the catheter body was noted ruptured at approximately 89.6cm from the distal tip of the catheter.The supplied control stroke syringe was not returned with the sample.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, a wrinkle was noted on the balloon; no damage or abnormalities were noted to the balloon.No condensation was noted within the inflation lumen extension line.No contrast media was noted within the injection lumen extension line.Spots of dried blood was noted on the exterior surfaces of the returned sample.No other damage or abnormalities were noted.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The balloon did meet specifications per graphic i-07135-003e rev.00 of radius ratio less than or equal to 2.0.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification i-07135-003e rev.00.No pull away was noted after the tug test.The balloon was placed in water and air was injected into the inflation lumen again.No leak was noted.The ruptured catheter body did not result in damage to the inflation lumen.The catheter's injection lumen was aspirated/flushed , and upon blocking the berman holes, air was noted leaking from the ruptured catheter body.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "catheter blew a puncture" is confirmed.The catheter body was found ruptured near the junction hub during visual inspection of the returned sample.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the ruptured catheter body.The probable root cause of the complaint is manufacturing related.A corrective and preventive action has been initiated to address the issue.Other remarks: n/a corrected data: n/a.

Event Description

Reported as "it was defective".It was reported that during use on a patient, the catheter blew a puncture hole at 500 psi and max is supposed to be 540 psi.As a result, another catheter was used.No medical intervention was needed.No report of patient harm or injury.Multiple inquiries regarding the insertion site of the second catheter were not answered by the customer.If additional information is received, the complaint file will be updated.

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16280224
• MDR Text Key: 308627163
• Report Number: 3010532612-2023-00041
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22L0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1