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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE; VASCULAR LOOP
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QUEST MEDICAL, INC SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE; VASCULAR LOOP Back to Search Results
Model Number 1541
Device Problems Break (1069); Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
The alleged issue occurred outside of the us.A similar device is distributed by quest medical in the us.The complaint sample is expected to be returned and an investigation will be completed when the device is received.A follow up medwatch will be submitted if additional information becomes available.
 
Event Description
A report was received regarding an alleged issue with the device.The report states that the tensioner was found to be damaged during use.There were no patient complications resulting from the alleged issue.
 
Manufacturer Narrative
The complaint samples were evaluated and cracks were seen along the weld line on the tensioner.The root cause of the crack is likely related to raw material molding issue.Quest issued a scar to the supplier for corrective action implementation.Quest will continue to monitor complaint trends for the reported complaint condition.
 
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Brand Name
SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE
Type of Device
VASCULAR LOOP
Manufacturer (Section D)
QUEST MEDICAL, INC
one allentown parkway
allen TX 75002
MDR Report Key9555814
MDR Text Key190529100
Report Number1649914-2020-00002
Device Sequence Number1
Product Code GAE
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 04/23/2020
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 Operator No Information
Device Model Number1541
Device Lot Number0588059G05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Initial Date Manufacturer Received 12/12/2019
Initial Date FDA Received01/06/2020
Supplement Dates Manufacturer Received12/12/2019
Supplement Dates FDA Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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