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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 5F BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERPICC CATHETER 5F BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number 6275118
Device Problems Partial Blockage (1065); Split (2537); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of recn1166 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that when inserting the guidewire through the needle, it "blocked/stopped" at approximately 20 cm.After removal, it showed a split at the tip of the guidewire.A very thin thread of metal was seen sticking out of the patient after removal of the guidewire as well.It was noted that the seldinger technique was used.No patient injury was reported.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 broken guidewire is confirmed and was determined to be use related.One guidewire was returned for evaluation.An initial visual observation showed the coiled wire and core wire of the guidewire were broken about 3.4 cm distal to the beginning of the coiled wire.The coiled wire was also observed to be unraveled from beginning of the coiled wire to approximately 1.4 cm proximal to the distal end.Use residue was observed on the sample.A microscopic observation revealed several kinks in the portion of the coiled wire that was not unraveled, near the distal tip.The fracture sites of the core wire and coiled wire were observed to be tapered and their surfaces were observed to be granular in texture, which is evidence of tensile failure.The product ifu states: ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of recn1166 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that when inserting the guidewire through the needle, it "blocked/stopped" at approximately 20 cm.After removal, it showed a split at the tip of the guidewire.A very thin thread of metal was seen sticking out of the patient after removal of the guidewire as well.It was noted that the seldinger technique was used.No patient injury was reported.
 
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Brand Name
POWERPICC CATHETER 5F BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER)
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
tesha udy
605 n. 5600 w.
salt lake city, UT 84116
8015225819
MDR Report Key7476054
MDR Text Key107216787
Report Number3006260740-2018-00865
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741139727
UDI-Public(01)00801741139727
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K051672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6275118
Device Lot NumberRECN1166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received05/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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