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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 Retraction Problem (1536); Infusion or Flow Problem (2964); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2019
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 not yet returned.
 
Event Description
It was reported that picc line would not flush despite administration of cathflo.After some troubleshooting, it was determined that the cause of this was a kink in the line in the axillary region (confirmed by xray).Hcp removed the dressing and tried to retract the picc to alleviate kink, but was unable to retract the catheter with moderate pressure.The line was inserted about a week ago.As the patient is elderly, hcp plans to transfer the patient to ir for removal (on april 8).
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint history, applicable previous investigation(s), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of catheter kinking was confirmed and appeared to be related to the use of the device.One 4 fr sl powerpicc solo catheter was returned with an infusion cap attached to the luer.The catheter extended up to the 45 cm depth marker.Use residue was present on the catheter.A sticker was returned with product information lot: recz1441.The catheter was microscopically examined.Wrinkling on the catheter surface was observed near the distal side of the 23 cm depth maker and 21 cm depth marker.The catheter was manipulated and was found to preferentially kink at locations with the material wrinkling.The catheter was cut near the 20 cm depth marker to measure the product dimensions.The catheter wall thickness and outer diameter were found to be within manufacturing specifications.Since the catheter showed evidence of kinking during use, the complaint is confirmed.The product ifu states, "avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen" and "avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort." a lot history review (lhr) of recz1441 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that picc line would not flush despite administration of cathflo.After some troubleshooting, it was determined that the cause of this was a kink in the line in the axillary region (confirmed by xray).Hcp removed the dressing and tried to retract the picc to alleviate kink, but was unable to retract the catheter with moderate pressure.The line was inserted about a week ago.As the patient is elderly, hcp plans to transfer the patient to ir for removal (on april 8).
 
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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 Key8552153
MDR Text Key143711728
Report Number3006260740-2019-01186
Device Sequence Number1
Product Code LJS
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 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
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 NumberRECZ1441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Event Location Hospital
Date Manufacturer Received07/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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