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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 Problems Fluid/Blood Leak (1250); Increase in Pressure (1491)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device has not yet been returned for evaluation.
 
Event Description
It was reported that a patient who has a 4fr powerpicc solo2 inserted to the right cephalic vein on (b)(6) 2018 for treatment of nec fasc with cloxacillin q4h via cadd infusion pump.As he was nearing completion of therapy he allegedly began to complained of pain with flushing that appeared to ascend the arm from exit site of the picc.His initial picc measurements 46cm trimmed length and 1cm external measurement, which remained the same until the picc was removed.The picc was removed on (b)(6) (not sure of exact date) and at that time the picc seemed to be leaking about 25cm from the hub, but intact afterwards to the tip.The picc had been unblocked with alteplase at one point, and had intermittent high pressure alarms.
 
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 leak is confirmed and is likely related to the use of the device.One 4 fr powerpicc solo catheter was returned for investigation.Residual use material was present within the catheter.The catheter extended up to the 45 cm depth marker.Catheter damage was observed near a bend in catheter at the 19 cm depth marker.The catheter was flushed with water using a 12 ml syringe and was observed to be occluded.Additional pressure resulted in white residual material leaking from the damaged portion of the catheter.The segment distal to the split was found to be occluded.Microscopic observation of the leak location revealed a circumferential split in the catheter.One side of the split surfaces was rough and granular.The opposite surface was observed to have a smoother surface finish.The characteristics of the split are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that a patient who has a 4fr powerpicc solo2 inserted to the right cephalic vein on (b)(6) 2018 for treatment of nec fasc with cloxacillin q4h via cadd infusion pump.As he was nearing completion of therapy he allegedly began to complained of pain with flushing that appeared to ascend the arm from exit site of the picc.His initial picc measurements 46cm trimmed length and 1cm external measurement, which remained the same until the picc was removed.The picc was removed on (b)(6) (not sure of exact date) and at that time the picc seemed to be leaking about 25cm from the hub, but intact afterwards to the tip.The picc had been unblocked with alteplase at one point, and had intermittent high pressure alarms.Picc removed, no ongoing harm.
 
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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 Key8189668
MDR Text Key131341250
Report Number3006260740-2018-03650
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,user f
Type of Report Initial,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number2194108
Device Lot NumberRECU1347
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Event Location Hospital
Date Manufacturer Received03/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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