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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)

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COVIDIEN ARGYLE STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) Back to Search Results
Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2018
Event Type  malfunction  
Manufacturer Narrative
Submit date: (b)(6) 2018 the incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reports there was a hole on the toe part of the catheter.
 
Manufacturer Narrative
The product received lot number differed from initial report. Therefore, correction is being made to reflect lot no. 1630600088. An investigation was performed for the reported customer complaint: ¿the customer reports there was a hole on the toe part of the catheter. ¿ a review of the device history record (dhr) for the returned product lot number 1630600088 indicated the product was released meeting all quality standards. All dhrs are reviewed for accuracy prior to product release. In-process procedures are also in place to prevent nonconforming product in the manufacturing process. This ensures components and finished products meet all quality inspection standards. These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification. A physical sample was returned for evaluation. The samples did not present signs of use. Visual evaluation revealed that one (1) the stockings presented a hole near the toe welt area; the borders of the hole appear to be cut out with a device that differs from the pieces used by the knitting machine, since the pattern was inconsistent with that created in the knitting machine. The packaging presents cuts consistent with scissors. The same cut pattern is observed on the polybag package of the sample. The event reported was confirmed. Potential root causes of the reported event could include: 1) customer manipulation - according to the evaluation executed to the sample returned by the customer, there was a hole near the toe welt area of the stocking, the same pattern of the hole is observed in the polybag of the product. Manufacturing internal process procedures provide controls to avoid a deficiency of this nature leaving the plant. Additionally, device history record review indicated that this lot was in compliance with internal procedures. Therefore, customer manipulation or mishandling is not discarded as a root cause. 2) visual inspection of the product not performed - according to the internal visual inspection process, during the packing process the operator executes a visual inspection of the product. There is also a final quality visual inspection and device history record review revealed that all product manufactured for this lot was in compliance according to process and product specifications. Therefore it is discarded as a root cause. 3) broken piece of the knitting machine ¿ should the stockings have an issue from the knitting process, the pattern of the hole would look different from the pattern observed from the sample. Therefore, it is discarded as a root cause. The reported customer complaint is confirmed. The root cause for this reported event was determined to be end use handling/misuse of the product. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameARGYLE
Type of DeviceSTOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
Manufacturer (Section D)
COVIDIEN
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7798697
MDR Text Key117702124
Report Number3009211636-2018-00284
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/02/2020
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1630600088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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