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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC KR, 5F, TL, MAX W/3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS DOT PPICC KR, 5F, TL, MAX W/3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number S1385108D
Device Problems Hole In Material (1293); Occlusion Within Device (1423); Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 07/07/2017
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 reaz0318 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the facility, via the sales rep, that the picc was inserted on (b)(6) 2017 with sherlock 3cg and site rite 8 in an icu patient.It was trimmed to 34cm, achieved max pwave with no negative deflection, left at 0cm out.The patient went to surgery sometime after insertion.On (b)(6) 2017 the picc team received a report that the line was sluggish.The picc rn administered cath flo in each lumen, only the red lumen was patent post cath flo.On (b)(6) 2017, the picc team received another notification that the line was occluded.A second picc rn administered cath flo in all lumens.They ordered cxr which showed the picc had malpositioned post-insertion with the tip in the subclavein.External catheter remained at 0cm.On (b)(6) 2017 a third picc rn pulled the line back to see how much would need to come out to get patency again to try and save the line until patient was discharge in a few days.Once 4-6 cm were external of the insertion site, she noticed raised ridges on the catheter as well as a hole.The line was removed and saved.
 
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 hole in the catheter was confirmed, and the cause appears to be associated with use of the device.One 5 fr t/l powerpicc provena was returned for investigation.The t/l tubing extended 35.5cm from the distal end of the trifurcation.A 2.4cm longitudinal strip of material deformation that extended outward from the catheter was observed between the 3 and 6 cm depth marks.A microscopic examination revealed that the deformed catheter material was split open between the 4 and 5 cm depth marks.The material exhibited evidence of deformation from expansion since the edge of the tubing along the split was noted to be wavy.The characteristics of the observed damage are consistent with rupture due to over-pressurization.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.A functional test revealed that fluid leaked from the longitudinal split when the lumen with the white luer adaptor (non-power injectable) was infused with water.It is unknown if this lumen was inadvertently used for a power injection.It was reported that the line was sluggish and/or occluded.The ifu warns, ¿use of lumens not marked ¿power injectable¿ for power injection of contrast media may cause failure of the catheter.¿ the wall thickness around the lumen with the white luer adaptor was found to be within specification.A recommended flushing and maintenance procedure is provided in the ifu to prevent occlusions within the catheter and damage to the device.The ifu states, ¿if resistance is met when flushing, no further attempts should be made.Further flushing could result in catheter rupture with possible embolization.Refer to institution protocol for clearing occluded catheters.¿ the ifu also states, ¿catheters that present resistance to flushing and aspiration may be partially or completely occluded.Do not flush against resistance.If the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.¿.
 
Event Description
It was reported by the facility, via the sales rep, that the picc was inserted on (b)(6) 2017 with sherlock 3cg and site rite 8 in an icu patient.It was trimmed to 34cm, achieved max pwave with no negative deflection, left at 0cm out.The patient went to surgery sometime after insertion.On (b)(6) 2017 the picc team received a report that the line was sluggish.The picc rn administered cath flo in each lumen, only the red lumen was patent post cath flo.On (b)(6) 2017, the picc team received another notification that the line was occluded.A second picc rn administered cath flo in all lumens.They ordered cxr which showed the picc had malpositioned post-insertion with the tip in the subclavian.External catheter remained at 0cm.On (b)(6) 2017 a third picc rn pulled the line back to see how much would need to come out to get patency again to try and save the line until patient was discharge in a few days.Once 4-6 cm were external of the insertion site, she noticed raised ridges on the catheter as well as a hole.The line was removed and saved.
 
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Brand Name
DOT PPICC KR, 5F, TL, MAX W/3CG
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
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key6750877
MDR Text Key81429398
Report Number3006260740-2017-01176
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741112720
UDI-Public(01)00801741112720
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/29/2017
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 Expiration Date04/30/2018
Device Model NumberS1385108D
Device Catalogue NumberS1385108D
Device Lot NumberREAZ0318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 07/24/2017
Initial Date FDA Received07/28/2017
Supplement Dates Manufacturer Received08/14/2017
Supplement Dates FDA Received08/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2016
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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