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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS; BAG, INTESTINE
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TELEFLEX MEDICAL EXTRACTION BAG FOR MIS; BAG, INTESTINE Back to Search Results
Catalog Number 332800-000010
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the part covering the wire of the memobag was torn for about 6cm when taking it out of the cavity after putting the tissue in it.Nothing fell/remained in the patient and no injury to the patient occurred.
 
Event Description
It was reported that the part covering the wire of the memobag was torn for about 6cm when taking it out of the cavity after putting the tissue in it.Nothing fell/remained in the patient and no injury to the patient occurred.
 
Manufacturer Narrative
(b)(4).The returned sample was examined.It is visible that the closure wire is threaded through all drilled holes.Part of the white protective tube inserted on the wire is missing.The end of the closure wire is glued to the bag through covering 8 mm white tube without damages.The loop of the closure where the wire is fixed on the bag is slightly deformed.It does not indicate usage of excessive force.The closure wire is permanently deformed in two areas where the protective white tube is missing.The detached white tube is longitudinally cut along the whole length.The wall of tube is thinner due to the stretching to approx.8 cm.As the lot number of the defective product was not reported, the dhr review of the complained lot could not be completed.The root cause of this complaint was determined as unintentional user error related.The customer did not follow the ifu during bag removal.It is evident from deformation of closure wire that the bag was not removed by appropriate tool which catches the loop at the end of closure wire but by graspers which caught the closure wire over the white tube.Within the removal, the graspers probably slid from the wire and teared off the white tube in 6 cm length.During the investigation the complained defect was successfully simulated.Customer complaint regarding memobag product was reported.As the lot number of the defective product was not reported, the dhr review was not completed.The reported defect can be confirmed.Part of the protective white tube covering the closure wire is detached from the wire.The root cause of this complaint was determined as unintentional user error related.The customer did not follow the ifu during bag removal and damaged the white protective tube by usage of wrong procedure for bag removal.As the root cause of this complaint was determined unintentional user error related, no corrective or preventive actions in production are deemed necessary to introduce.
 
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Brand Name
EXTRACTION BAG FOR MIS
Type of Device
BAG, INTESTINE
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
bryanna connelly
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key15789349
MDR Text Key306779750
Report Number3006425876-2022-00974
Device Sequence Number1
Product Code KGY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number332800-000010
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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