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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Model Number N/A |
Device Problems
Retraction Problem (1536); Infusion or Flow Problem (2964); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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