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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
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BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number 1275108D
Device Problems Knotted (1340); Physical Resistance (2578); Malposition of Device (2616)
Patient Problem No Information (3190)
Event Date 12/08/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebu0776 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the facility that it is unknown if there was any patient injury.It was stated that the indications were access and oxacillin for six weeks.It was stated that the site was prepped using 2% chlorhexidine.Maximum sterile technique was used including antiseptics, cap, gloves, gown, hand hygiene, mask, maximum barrier sheet and probe cover.It was also stated that the procedure was ultrasound guided, placed in the left upper arm, basilica vein approximately 5 cm above the antecubital fossa and the patient was placed supine.The facility stated "catheter tip in svc, confirmation with ecg tps technology".They reported that the statlock was applied and the site was dressed.Additional flushes were met with resistance, sluggish blood return.They stated "given suspected local kink, catheter site was undressed and repositioned with no improvement".The rn attempted an over the line exchange with a new catheter, however resistance was met with the guidewire.The catheter was then cut and removed with minor resistance at the end of the catheter removal, which was remedied with local vascular massage for suspected spasm.They reported that it was noted the catheter was knotted.Pressure was held on the site for about two minutes and it was dressed with gauze with no saturation.They stated that the left cephalic was then accessed, however they were unable to advance the guidewire without resistance and the procedure was aborted.
 
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 a knot in the catheter was confirmed, and it appeared that the damage occurred during use.Two photographs were provided for investigation.Both photos showed a knot in purple tubing.Use residue was observed on the tubing.Only a segment of the tubing was shown in the photo.The hub and connectors are not visible in the photo.The 2nd photo showed white depth markers on the catheter, which is not consistent with the implicated product or any bard/bd powerpicc.Additional information provided by the complainant indicated that "the second picture was just an example".The knot may have inadvertently folded over itself and was twisted into a knot within the vessel.Had the knot existed prior to use, the catheter would have been able to advance through an introducer sheath, which indicates that the damage occurred during use.Without the physical sample, it could not be determined if the stylet was captured within the knotted area of the catheter.A lot history review (lhr) of rebu0776 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the facility that it is unknown if there was any patient injury.It was stated that the indications were access and oxacillin for six weeks.It was stated that the site was prepped using 2% chlorhexidine.Maximum sterile technique was used including antiseptics, cap, gloves, gown, hand hygiene, mask, maximum barrier sheet and probe cover.It was also stated that the procedure was ultrasound guided, placed in the left upper arm, basilica vein approximately 5 cm above the antecubital fossa and the patient was placed supine.The facility stated "catheter tip in svc, confirmation with ecg tps technology".They reported that the statlock was applied and the site was dressed.Additional flushes were met with resistance, sluggish blood return.They stated "given suspected local kink, catheter site was undressed and repositioned with no improvement".The rn attempted an over the line exchange with a new catheter, however resistance was met with the guidewire.The catheter was then cut and removed with minor resistance at the end of the catheter removal, which was remedied with local vascular massage for suspected spasm.They reported that it was noted the catheter was knotted.Pressure was held on the site for about two minutes and it was dressed with gauze with no saturation.They stated that the left cephalic was then accessed, however they were unable to advance the guidewire without resistance and the procedure was aborted.
 
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Brand Name
POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY
Type of Device
PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
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
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key7155010
MDR Text Key96230950
Report Number3006260740-2017-02345
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741034558
UDI-Public(01)00801741034558
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Model Number1275108D
Device Catalogue Number1275108D
Device Lot NumberREBU0776
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age52 YR
Patient Weight74
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