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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 FX45 2N 48" BARD
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TELEFLEX MEDICAL DEK BL MF 0 FX45 2N 48" BARD Back to Search Results
Catalog Number DEK200
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during a sacro-spinal fixation when the surgeon fired the fixt the bullet broke off the suture.The bullet was in the patient and the doctor had only the suture in his hands.They had found the bullet with x-ray and it was possible to remove the bullet.The patient's condition is unknown at this time.
 
Manufacturer Narrative
(b)(4).The customer returned one unit 543965 autoendo5 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears used as there is biological material present on the device.No other defects or anomalies were observed.Reference attached functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, no ratchet sound could be heard indicating that the internal ratchet ears are broken.No clip fired.The trigger was engaged several more times with no clips firing.The sample was disassembled to inspect the internal components.Upon disassembly, no further damages were found.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.The ifu for this product, l03496, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." other remarks: a corrective action is not required at this time as the condition of the sample received indicates that operational context caused or contributed to this event.Although no clips were returned, the broken ratchet ears could lead to loading issues.The reported complaint of "handle stops" was not confirmed based upon the sample received.One device was returned.The device was returned with 0 clips remaining.Upon functional inspection, it was found that the internal ratchet ears were broken.However, the handle was able to complete its cycle and never got stuck.The damage to the ratchet ears could affect the end user's ability to properly load and apply clips and could cause the handle to get stuck.At the time of manufacturing assembly, the autoendo5 is 100% inspected for proper clip loading and closure.It is unlikely that this type of damage was present at the time of manufacturing.A device history record review was performed on the autoendo5 with no evidence to suggest a manufacturing related cause.Although the reported complaint issue could not be confirmed since the handle was able to complete its cycle and never got stuck, the broken internal ratchet ears and the bent tube could cause issues with the loading of the clips and could cause the handle to get stuck.Therefore, based upon the observed damage, operational context caused or contributed to this event.No further action will be taken.
 
Event Description
It was reported that during a sacro-spinal fixation when the surgeon fired the fixt the bullet broke off the suture.The bullet was in the patient and the doctor had only the suture in his hands.They had found the bullet with x-ray and it was possible to remove the bullet.The patient's condition is unknown at this time.
 
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Brand Name
DEK BL MF 0 FX45 2N 48" BARD
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6912330
MDR Text Key89692783
Report Number3004365956-2017-00361
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/18/2017
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 Catalogue NumberDEK200
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/18/2017
Initial Date FDA Received10/03/2017
Supplement Dates Manufacturer Received09/29/2017
Supplement Dates FDA Received11/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
Patient Weight80
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