MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-BLOCKER KIT; EZ BLOCKER

Model Number	IPN913391
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint reports that: "ez blocker balloons both independently inflating and/or deflating on their own.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed on a potential lot number reported by the customer and no relevant findings were identified.The manufacturing site reports that "based on communication with supplier of catheters, the reported defect was confirmed as "supplier related.Defect is probably caused by small cross-leak between balloons." it was also reported that the supplier opened a non-conformance in order to further investigate.
Event or Problem Description
The complaint reports that: "ez blocker balloons both independently inflating and/or deflating on their own.".No patient injury reported.The condition of the patient was listed as "fine".

• Brand Name: EZ-BLOCKER KIT
• Common Device Name: EZ BLOCKER
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15484461
• Report Number: 3006425876-2022-00838
• Device Sequence Number: 8133022
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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 Model Number: IPN913391
• Device Catalogue Number: MG-02770-002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown