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

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.

• 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 Key: 6750877
• MDR Text Key: 81429398
• Report Number: 3006260740-2017-01176
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741112720
• UDI-Public: (01)00801741112720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053501
• Number of Events Reported: 1
• 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 Date: 04/30/2018
• Device Model Number: S1385108D
• Device Catalogue Number: S1385108D
• Device Lot Number: REAZ0318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1