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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen3317 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the device was not used on a patient, prior to use the hub area had a white substance that looked like corrosion.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign material in the device was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 21ga safety introducer needle.The sample appeared free of obvious usage residues and the safety mechanism was not engaged.A region of what appeared to be material discoloration was observed at the interface between the luer material and the needle shaft.Microscopic inspection of the sample confirmed a region of material discoloration at the luer/needle interface.Following bisection of the sample within the discolored region, inspection of the material did not reveal any obvious deformation.The reported ¿white substance¿ appeared to be referring to the observed region of material discoloration.Such discoloration may be the result of internal stresses experienced by the luer polymer material during or following device manufacture, but did not appear cause any device defect or disfunction.Consequently this complaint is unconfirmed at this time.A lot history review (lhr) of reen3317 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the device was not used on a patient, prior to use the hub area had a white substance that looked like corrosion.
 
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Brand Name
POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
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
MDR Report Key10518759
MDR Text Key206521324
Report Number3006260740-2020-03224
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741138973
UDI-Public(01)00801741138973
Combination Product (y/n)N
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/30/2020
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 Date06/30/2021
Device Model NumberN/A
Device Catalogue Number2194108
Device Lot NumberREEN3317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Event Location Hospital
Initial Date Manufacturer Received 08/18/2020
Initial Date FDA Received09/10/2020
Supplement Dates Manufacturer Received09/16/2020
Supplement Dates FDA Received09/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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