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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 Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recw1442 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
 
Event Description
It was reported that staff have noticed that piccs are flipping and becoming internally malpositioned more often.Staff wondered if the picc had changed and took a single lumen solo picc from current kit, and compared it to a previous sample they had.Based on visual inspection, current picc supposedly looks ¿thinner¿ than sample.Staff are wondering if formula for picc polyurethane, or mould for piccs has changed, leading to increased malpositions.Both the current picc and previous sample are available and will be sent in.This has allegedly happened a few times but cannot identify exact times or details.
 
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 catheter malposition is inconclusive due to poor sample condition.One 4 fr sl powerpicc catheter was returned for investigation.The catheter extended up to the 55 cm depth marker and appears to have not been trimmed.A product label was returned with lot: recw1442.The stylet t-lock assembly was returned within the catheter.A kink was present on the catheter between the 9 and 10 cm depth marker.No evidence of use was observed.Microscopic observation of the catheter revealed no apparent defects.The catheter was measured at the 0 cm, 15 cm and 30 cm depth markers and the outer diameter of the catheter was found to be within specification.Since the returned sample showed no evidence of use and no apparent issues were observed, the event of catheter malposition could not be confirmed; therefore, the complaint is inconclusive due to poor sample condition.A lot history review (lhr) of recw1442 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that staff have noticed that piccs are flipping and becoming internally malpositioned more often.Staff wondered if the picc had changed and took a single lumen solo picc from current kit, and compared it to a previous sample they had.Based on visual inspection, current picc supposedly looks ¿thinner¿ than sample.Staff are wondering if formula for picc polyurethane, or mould for piccs has changed, leading to increased malpositions.Both the current picc and previous sample are available and will be sent in.This has allegedly happened a few times but cannot identify exact times or details.
 
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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
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 Key8295251
MDR Text Key134712603
Report Number3006260740-2019-00140
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741138973
UDI-Public(01)00801741138973
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
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 NumberRECW1442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received03/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2018
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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