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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 IPN917235
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The report states that "we used 2 different berman 5 x 80 catheters today and both times the hub cracked during an injection.We were within the limits of psi and flow rates listed on the package.They were both from the same lot." additional information states "the catheters were used on the same patient.Physician was able to see enough of the lv with the partial injection.No medical intervention was required.Pt went home as planned." see associated mdr 3010532612-2023-00047.
 
Event Description
The report states that "we used 2 different berman 5 x 80 catheters today and both times the hub cracked during an injection.We were within the limits of psi and flow rates listed on the package.They were both from the same lot." additional information states "the catheters were used on the same patient.Physician was able to see enough of the lv with the partial injection.No medical intervention was required.Pt went home as planned." see associated mdr 3010532612-2023-00047.
 
Manufacturer Narrative
(b)(4).The lot number reported is 16f22l0045.The lot number of the returned device is suspected to be from the reported lot; however, no original packaging/label was returned.Returned for investigation was a 5fr.80cm berman catheter without the original packaging.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 89.5cm to 89.7cm 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 open position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, the balloon appeared.No condensation was noted within the inflation lumen extension line.Spots of dried blood were noted within the injection lumen extension line.Spots of dried blood were 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 the returned 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 of radius ratio less than or equal to 2.0.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 that the "hub cracked during an injection" is confirmed.The catheter body was found damaged/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 damaged/ruptured catheter body.The root cause of the damaged/ruptured catheter body is undetermined.Other remarks: n/a.Corrected data: n/a.
 
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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 Key16271716
MDR Text Key308555690
Report Number3010532612-2023-00045
Device Sequence Number1
Product Code DYG
UDI-Device Identifier10801902180787
UDI-Public10801902180787
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2024
Device Model NumberIPN917235
Device Catalogue NumberAI-07135
Device Lot Number16F22L0045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received03/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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