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

Model Number IPN913391

Device Problem Inflation Problem (1310)

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "doctor tried to inflate yellow balloon only, but blue balloon also got inflated".No patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The actual sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports that a visual exam was performed and no defects were observed.It was also reported that functional testing was performed and the yellow balloon was inflated by 15ml of air.The blue balloon did not inflate; however, gradually air from the yellow balloon began to flow into the blue balloon.After a few minutes the amount of air in both balloons equalized.A device history record review was performed and no relevant findings were identified.The manufacturing site reports that the complaint was confirmed.The root cause is listed as supplier related.A non-conformance was opened to address this issue.

Event Description

It was reported "doctor tried to inflate yellow balloon only, but blue balloon also got inflated".No patient involvement reported.

• Brand Name: EZ-BLOCKER KIT
• Type of Device: 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
• MDR Report Key: 12583612
• MDR Text Key: 274958717
• Report Number: 3006425876-2021-00923
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K121462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2022
• Device Model Number: IPN913391
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 71F20H1612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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