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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number CK000375
Device Problems Bent (1059); Uncoiled (1659); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2018
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 recn0394 showed two other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during insertion the placer observed resistance guiding the picc past the axilla.It was stated she removed the picc and noted that the end of the stylet had started to unwind.She bent the stylet and it snapped.Another picc was opened to check the length of the stylet to ensure nothing had been left in the patient.Confirmed that removed stylet was the correct length.
 
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: one 3cg stylet with the t¿lock and white fin assembly were returned for investigation.The stylet was broken near the distal end.Kinks were observed on the polyimide tubing of the fractured segment.The core wire was observed to extend 16 mm past the break location.Use residue was observed throughout the sample.Microscopic observation of the proximal end of the break site showed material deformation.This is indicative of compressional forces caused during bending or kinking.Based on the use residue, damage on the returned product, and event description indicating resistance was felt during placement, the complaint is confirmed to be use related.The ifu states ¿warning: ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter, combined with kinking and excessive forces may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury¿ and ¿never use force to remove the stylet.¿ a lot history review (lhr) of recn0394 showed two other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during insertion the placer observed resistance guiding the picc past the axilla.It was stated she removed the picc and noted that the end of the stylet had started to unwind.She bent the stylet and it snapped.Another picc was opened to check the length of the stylet to ensure nothing had been left in the patient.Confirmed that removed stylet was the correct length.
 
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Brand Name
POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
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
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7603927
MDR Text Key111849021
Report Number3006260740-2018-01397
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741102660
UDI-Public(01)00801741102660
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCK000375
Device Lot NumberRECN0394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
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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