MAUDE Adverse Event Report: Z-MEDICA, LLC QC CONTROL+, 3" X 2 YD Z-FOLD, 10X; TEMPORARY, INTERNAL USE HEMOS

Catalog Number	4020
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and 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
Trauma patient came in from car accident.Qc c+ was used to pack liver bleed, patent went to icu and next day went to x-ray.Radiologist was not aware of qc being left in the patient and could not see any detection at first pass/initial read.Product was left in patient and radiologist took a second look and was able to see the x-ray detectable strip the second time.Product was in for at least 24 hrs.All product was removed at this time.Sounds like there is no patient harm.The patient returned to surgery after it was discovered the z-fold was left in place inadvertently.They returned to surgery and it was removed successfully.The concern was that the z-fold is not easily recognizable on an xray.

• Brand Name: QC CONTROL+, 3" X 2 YD Z-FOLD, 10X
• Common Device Name: TEMPORARY, INTERNAL USE HEMOS
• Manufacturer (Section D): Z-MEDICA, LLC; wallingford
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21065101
• Report Number: 3011137372-2025-00004
• Device Sequence Number: 16969608
• Product Code: POD
• UDI-Device Identifier: 10841495150026
• UDI-Public: (01)10841495150026(11)240613(17)270913(10)44F24F0019(21)
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220971
• 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
• Report Date (Section B): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4020
• Device Lot Number: 44F24F0019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2024
• 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: NOT REPORTED.
• Patient Sex: Unknown