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

Catalog Number	AI-07135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " it was reported that air kept leaking from the hub side during use.Therefore, a new kit was used instead".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The lot number reported is 16f22l0062.Returned for investigation was a 5fr.80cm berman catheter without the original packaging.The sample was returned in the ups shipping box and was in a sealed ziploc bag.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 89.8cm to 90.2cm 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 typical; no damage or abnormalities were noted to the balloon.No condensation was noted within the inflation lumen extension line.Dried contrast media were noted within the injection lumen extension line.Dried blood/contrast media were noted on the exterior surfaces of the returned sample.Some dried contrast media was noted within the interior surfaces (at the location of the ruptured catheter body) 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 per graphic 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 per specification.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 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 "air kept leaking from the hub side during use" 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 was opened/closed for this issue and the product was manufactured prior to the corrective actions.
Event or Problem Description
It was reported that " it was reported that air kept leaking from the hub side during use.Therefore, a new kit was used instead".No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Common Device Name: 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20016288
• Report Number: 3010532612-2024-00667
• Device Sequence Number: 15621910
• Product Code: DYG
• UDI-Device Identifier: 00801902002273
• UDI-Public: (01)00801902002273(11)221122(17)240430(10)16F22L0062(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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 Expiration Date: 04/30/2024
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22L0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown