C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 3CG 4F BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
|
Back to Search Results |
|
Model Number 1194118 |
Device Problem
Material Deformation (2976)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/28/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
|
|
Event Description
|
It was reported that powerpicc solo catheters developing mechanical occlusions(kinking) in-situ after insertion.It has been happening periodically over some time, but feel it has been increasing.The insertions were unremarkable with no difficulties, flushed and aspirated without resistance on insertion but patients developed occlusions.They did not indicate is happening more often with sl, dl or tl picc's.For some of the patients they were able to pull the picc back a 1-2 cm's to correct the kink but other required removal and insertion of new picc.No other information was provided.
|
|
Event Description
|
It was reported that powerpicc solo catheters developing mechanical occlusions(kinking) in-situ after insertion.It has been happening periodically over some time, but feel it has been increasing.The insertions were unremarkable with no difficulties, flushed and aspirated without resistance on insertion but patients developed occlusions.They did not indicate is happening more often with sl, dl or tl picc's.For some of the patients they were able to pull the picc back a 1-2 cm's to correct the kink but other required removal and insertion of new picc.No other information was provided.
|
|
Manufacturer Narrative
|
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter kink is confirmed but the exact cause remains unknown.One radiographic image of a catheter within a patient were provided for evaluation.The first image appears to show a catheter within a patient left arm.The molded wing hub is visible.The catheter appears to loop around itself creating a kinked region.Based on the description of the reported event and images provided, possible contributing factors include manipulation of the catheter during use, placement location, and securement technique.Since the image appeared to depict an internal kink of the catheter, the complaint is confirmed but the exact factors remain unknown.
|
|
Search Alerts/Recalls
|
|
|