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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/10/2018
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recs0332 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recs0332) have been reported from the same facility.
 
Event Description
It was reported that during insertion the vein looked good on ultrasound, wire deployed well, but there was difficulty deploying catheter.The rn attempted to retract wire and remove device, device pulled back guide wire still in arm, able to manually remove guide wire with a little pull.It was stated wire appeared intact, later testing revealed patient had old vietnam shrapnel in his upper arm.A new device was not placed after the event.No patient harm, x-ray done on upper arm and chest, later ct scan determined old shrapnel in place.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The sample was received with the catheter overlaying the needle.The needle was perforating the catheter wall.The guidewire slider was withdrawn and the wire did not extend past the needle tip.The guidewire was initially immobile due to blood residue within the needle shaft.Mobility was re-established following device manipulation.Following guidewire advancement, inspection of the distal tip revealed a complete break.The distal end of the wire was not returned for evaluation.Microscopic inspection of the break in the core wire revealed a granular fracture surface.The fracture exhibited a region of increased luster.Curved shape memory was observed in the vicinity of the break.Inspection of the needle bevel revealed outward flaring deformation along the proximal edge.The region of increased luster in the core wire and the needle bevel damage were consistent with wire damage initiated by withdrawal against the needle bevel.The catheter damage was also consistent with catheter withdrawal.The blood residue indicated that damage occurred during attempted device insertion.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.¿ a lot history review (lhr) of recs0332 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recs0332) have been reported from the same facility.
 
Event Description
It was reported that during insertion the vein looked good on ultrasound, wire deployed well, but there was difficulty deploying catheter.The rn attempted to retract wire and remove device, device pulled back guide wire still in arm, able to manually remove guide wire with a little pull.It was stated wire appeared intact, later testing revealed patient had old vietnam shrapnel in his upper arm.A new device was not placed after the event.No patient harm, x-ray done on upper arm and chest, later ct scan determined old shrapnel in place.
 
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Brand Name
FULL KIT 18G X 10 CM WITH PROBE COVER
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7985276
MDR Text Key124560704
Report Number3006260740-2018-02942
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741140617
UDI-Public(01)00801741140617
Combination Product (y/n)N
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberF218108PT
Device Lot NumberRECS0332
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2018
Event Location Hospital
Date Manufacturer Received10/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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