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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIDI PRODUCTS, LLC QUICK-RELEASE TWICE-AS-TOUGH CUFFS RESTRAINT, PROTECTIVE

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TIDI PRODUCTS, LLC QUICK-RELEASE TWICE-AS-TOUGH CUFFS RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2791Q
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A pair of restraints was received from two different lot numbers: 0281t018 and 1322t019. The quick release buckles for the bed connecting straps on both restraints are coming apart. No other abnormalities have been observed. Engineering team performed pull test from the same raw materials that were used on the returned restraints by using dhr information. The team followed aql 1. 0 based on number of sales sold from the last 12 months. Subsequently, 60 sample units were taken into account for pull testing as an effort of complaint recreation, but the pull test result did not present a low yield that would suggest a manufacturing process of the buckle may have contributed to the reported issue. Per drawing h0551c rev. F, the required tensile strength for the quick release buckle is 200 lbs. All 60 units passed the pull test requirement as the minimum pull force was 207. 02 lbs. And the maximum force was 473. 28 lbs. With an average of 284. 96 lbs. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. Manufacturer reference file (b)(4).
 
Event Description
Customer reported via email the clip on this item is breaking. Stating it's happened numerous times. The date the issue was discovered is unknown and no incident or serious injury was reported.
 
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Brand NameQUICK-RELEASE TWICE-AS-TOUGH CUFFS
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
TIDI PRODUCTS, LLC
570 enterprise drive
neenah WI 54956
Manufacturer Contact
chris rahn
570 enterprise drive
neenah, WI 54956
9207514300
MDR Report Key14336850
MDR Text Key291954071
Report Number2182318-2022-00039
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2791Q
Device Catalogue Number2791Q
Device Lot Number0281T018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2022
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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