C.R. BARD, INC. (BASD) -3006260740 4FR DL PROVENA MIDLINE MAX BARRIER KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number S4254108BDP |
Device Problems
Fluid/Blood Leak (1250); Unintended Movement (3026)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reew1908 showed no other similar product complaint(s) from this lot number.H3 other text : device not returned for evaluation.
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Event Description
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It was reported the external purple lumen came out of the y or wings of the catheter, clean, full catheter without shards or tearing; empty hole leaking noted from primary rn.Catheter was trimmed to 18 cm with 1 cm out, placed with ease in the basilic vessel, and secured with statlock.
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Event Description
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It was reported "so wit was reported the external purple lumen came out of the y or wings of the catheter, clean, full catheter without shards or tearing; empty hole leaking noted from primary rn.Catheter was trimmed to 18 cm with 1 cm out, placed with ease in the basilic vessel, and secured with statlock.
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Manufacturer Narrative
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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 leak is confirmed but the exact cause remains unknown.Three photo samples of a 4 fr dl provena midline catheter were provided for evaluation.The first photo shows the extension tubing of a powermidline catheter within one of the ends covered in gauze.No apparent damage can be clearly observed on the extension tubing.The next two photo shows the purple luer hub and extension tubing.The distal end of the extension tubing is shown.The surface characteristics are not clearly visible; however, the surface appears to be even and flat.Based on the photo samples provided, possible contributing factors include tensile damage, sharp instrument damage, and material fatigue caused by repeated kinking.Since the extension leg was observed to be detached, the complaint is confirmed but the exact cause remains unknown.
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