BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM INTERMEDIATE KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
|
Back to Search Results |
|
Model Number F120081 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
Pain (1994)
|
Event Date 06/21/2018 |
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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recq0391 showed no other similar product complaint(s) from this lot number.
|
|
Event Description
|
It was reported that after placement, the midline had kinked internally and was causing pain.The device was subsequently removed.No patient injury was reported.
|
|
Manufacturer Narrative
|
The following were reviewed as part of this investigation: patient severity, trend 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 kinked powerglide catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 8cm powerglide midline catheter.The sample was received attached to an extension set.Usage residues were observed throughout the sample.A permanent kink impression was observed 2.8cm from the distal tip of the catheter.Tactile inspection of the sample confirmed the presence of a permanent kink.Microscopic inspection of the distal end of the sample revealed buckling near the distal tip of the catheter.The tip of the catheter exhibited discoloration and deformation.The compressed and buckled tip of the catheter suggested that difficulty was experienced during catheter insertion.The kink in the tubing was consistent with device manipulation during that apparent insertion difficulty.A lot history review (lhr) of recq0391 showed no other similar product complaint(s) from this lot number.
|
|
Event Description
|
It was reported that after placement, the midline had kinked internally and was causing pain.The device was subsequently removed.No patient injury was reported.
|
|
Search Alerts/Recalls
|
|
|