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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED Back to Search Results
Model Number IPN923529
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Event Description
It was reported that the catheter was found torn near the hub during the procedure.The catheter was replaced with a new one at the same insertion site.The user did not notice the tear at the beginning of the procedure.No harm to the patient was reported.Patient condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).The reported lot number (16f21m0029) matches the lot number on the returned original packaging pouch/label.Returned for investigation was a 5fr.80cm berman catheter with the original packaging pouch.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 88.9cm to 89.5cm from the distal tip of the catheter.The supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the closed position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, a wrinkle was noted on the balloon; no damage was 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.Dried blood/contrast media was noted within the berman holes (injection lumen) near the catheter tip.Dried blood was noted on the exterior of the sample.No other damage or abnormalities were noted.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed.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 damaged/ruptured catheter body did not result in damage to the inflation lumen.The catheter's injection lumen was aspirated/flushed, and air was noted leaking from the damaged/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 of catheter body cut/torn during use is confirmed.The catheter body was found ruptured near the junction hub upon receipt of the 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 root cause of the ruptured catheter body is undetermined.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that the catheter was found torn near the hub during the procedure.The catheter was replaced with a new one at the same insertion site.The user did not notice the tear at the beginning of the procedure.No harm to the patient was reported.Patient condition is reported as "fine".
 
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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
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key15919576
MDR Text Key307794042
Report Number3010532612-2022-00548
Device Sequence Number1
Product Code DYG
UDI-Device Identifier10801902206654
UDI-Public10801902206654
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Model NumberIPN923529
Device Catalogue NumberAI-07135
Device Lot Number16F21M0029
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received01/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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