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

Catalog Number	MG-02770-002
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, "both the cuffs are getting inflated".No patient harm or injury.The patient status is reported as "fine".At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4), complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon several lot numbers taken from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that while in use on a patient, "both the cuffs are getting inflated".No patient harm or injury.The patient status is reported as "fine".At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4) the sample was returned to the manufacturer for evaluation.The manufacturer reported that: "one complained device was avaible for e valuation.Complained catheter was visually checked.No defect causing reported issue was identified.Reported defect could not be determined from visual inspection.Reported defect cannot be confirmed based on functional test.Based on all stated information, claimed defect was not confirmed.A detected catheter defect would not allow a positive leak test result.As the lot number of the dective product was not reported, only the dhr review of the potential lots based on sales history could be completed.The review of the dhr's revealed no production issues from the perspective of the reported defect.The root cause of this complaint determined as "unintentional user error related".The issue cannot be confirmed based on the delivered sample of the defective product.Based on the testing, there was observed different issue than was reported.This issue is most probably caused by sharp tool on customer side.Manufacturing and packaging processes were reviewed.No abnormal data leading to occurrence of complained or similar defects were detected.Reported issues should be detected on final leak test step.As the root cause of this complaint was determined as unintentional user error related, no corrective i preventive actions in production are deemed necessary to introduce.Customer complaint regarding ez-blocker product was reported.The reported defect cannot be confirmed but other issue on the sample was observed.As the lot number of the defective product was not reported, only the dhr review of the potential lots based on sales history was completed.The root cause of this complaint was determined as unintentional user error related.The reported defect was not confirmed but another issue was revealed.This issue was most probably caused by a sharp tool on the customer site.As the root cause of this complaint was determined as unintentional user error related, no corrective i preventive actions in production are deemed necessary to introduce." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient, "both the cuffs are getting inflated".No patient harm or injury.The patient status is reported as "fine".At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17479591
• Report Number: 3006425876-2023-00817
• Device Sequence Number: 11424938
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 1897418206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/07/2023; 05/23/2025
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/11/2023; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown