MAUDE Adverse Event Report: Z-MEDICA, LLC QUIKCLOT INTERVENTIONAL,PRESLIT,MULTI-LANG,10X; DRESSING, WOUND, DRUG

Catalog Number	188
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "staff in micu were trialing/evaluating pre-slit for cvc line bleeding/oozing.After initial placement of gauze was saturated and replaced again and same occurrence and replaced again.Hemostasis was not achieved so alternative actions taken 3 failed attempts.According to the (b)(6) there was no harm or health consequences to the patient." associated complaints 3011137372-2025-00115 and 3011137372-2025-00116.
Additional Manufacturer Narrative
Qn #: (b)(4).The complaint device was not received at our manufacturing site for evaluation.There are no indications that the product failed to function as intended.A review of manufacturing process revealed that the coat weights recorded for this lot of dressing pads had a 2.86 cpk which indicates the coating process of kaolin was well controlled.A device history record review was performed, and no relevant findings were identified.An assessment of the reported event and the instructions for use (ifu) suggests that the instructions may not have been followed as specified.The ifu states: "apply firm, non-occlusive manual compression on the pad for at least 5 minutes or until bleeding/oozing stops." based upon this evaluation, unintentional use error (failure to follow ifu) likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "staff in micu were trailing/evaluating pre-slit for cvc line bleeding/oozing.After initial placement of gauze was saturated and replaced again and same occurrence and replaced again.Hemostasis was not achieved so alternative actions taken 3 failed attempts.According to the nm there was no harm or health consequences to the patient." associated complaints 3011137372-2025-00117, 3011137372-2025-00115 and 3011137372-2025-00116.

• Brand Name: QUIKCLOT INTERVENTIONAL,PRESLIT,MULTI-LANG,10X
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): Z-MEDICA, LLC; wallingford
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21806168
• Report Number: 3011137372-2025-00117
• Device Sequence Number: 15662187
• Product Code: QSY
• UDI-Device Identifier: 10841495150248
• UDI-Public: (01)10841495150248(11)230919(17)251219(10)44F23J0019(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120782
• 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): 03/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2025
• Device Catalogue Number: 188
• Device Lot Number: 44F23J0019
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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; NOT REPORTED
• Patient Sex: Unknown