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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

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COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER Back to Search Results
Model Number G47942
Device Problem Material Frayed (1262)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation = inventory manager.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
 
Event Description
As reported, a wire included in the micropuncture transitionless access set was found to be frayed upon removal from the package.The device did not make contact with any patient.
 
Event Description
No new patient or event information since the last report was submitted.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: cook was informed of an incident involving a micropuncture transitionless access set.The unused wire guides reportedly were defective.Attempts to acquire additional information from the user facility were executed, however no additional information was provided to cook in response to this incident.No additional harm was reported.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, drawing, the instructions for use, manufacturing instructions, and quality control data.Five sealed wire guides were received for investigation.The packages were opened to examine the wires, and no visible damage to the coils or wires were noted.At this time, cook concluded that the devices were manufactured within specification.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows one other complaints associated with the complaint device lot, however, the unused devices returned for this complaint had no damage noted.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded that no device issue was noted to the returned devices.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
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Brand Name
MICROPUNCTURE TRANSITIONLESS ACCESS SET
Type of Device
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key11193963
MDR Text Key258854377
Report Number1820334-2021-00115
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002479425
UDI-Public(01)00827002479425(17)231112(10)13554764
Combination Product (y/n)N
PMA/PMN Number
K171275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/11/2021
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 Health Professional
Device Expiration Date11/12/2023
Device Model NumberG47942
Device Catalogue NumberMPIS-401-NT-SST
Device Lot Number13554764
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Initial Date Manufacturer Received 12/29/2020
Initial Date FDA Received01/19/2021
Supplement Dates Manufacturer Received03/10/2021
Supplement Dates FDA Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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