SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECTIV PLUS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
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Model Number 306601 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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One jelco safety protective plus catheter was returned for analysis without the severed tube segment, needle guard assembly, sheath, or blister packaging.The sample was examined under magnification and photographed.The eyelet to tube securement area within the catheter hub was intact with no evidence of catheter securement issues.Examination of the catheter assembly noted that the catheter tube was severed at 1/16" above the catheter hub nose.Examination of the catheter hub displayed evidence of damage to the catheter hub nose.The manufacturing process was reviewed; an issue with low puck count in the pcm2 bevel module on a shift in may with no cause established.An attempt to replicate the damage found in the faulted sample was performed to another sample.It too was examined under magnification and photographed finding similarity to the complaint sample.The replicate sample also displayed evidence of a puncture in the catheter tubing, but the shape of the damage to the catheter tube differs from the complaint sample.Based on the evidence, the complaint was confirmed.The root cause was found due to manufacturing.
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Event Description
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Information was received indicating that upon removal of a smiths medical jelco safety protective plus catheter, the catheter broke off at the hub, leaving the tip in the cephalic vein.Vascular surgery was reported to remove the fragment in the operating room.There were no further reported adverse effects.
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