C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regn4045 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported by the customer that when placing the catheter in this patient, the head nurse found black extraneous substance near the valve in the catheter.No other information was provided.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of black extraneous substance near the valve in the catheter is confirmed.One 4 fr s/l nxt clearvue groshong catheter was returned for evaluation.An initial visual observation showed use residues throughout the catheter and stylet.Blood was present throughout the outside of the catheter and the inside of the catheter.A dark substance was located at the distal end of the catheter near the valve.A functional test of pressurizing the catheter with water using a 12 ml syringe cleared the catheter of most foreign substances.The catheter was pressurized over several white paper towels to catch anything that exited the returned device.A microscopic observation revealed abundant blood use residues present throughout the catheter and the stylet before the device was pressurized with water.After the catheter was pressurized with water, a microscopic observation revealed the dark substance at the distal end of the catheter near the valve to be mostly gone.The dark substance caught by the paper towel appeared to be blood.A dark substance near the distal end of the valve of a groshong catheter was confirmed and determined to be blood residues.After evaluation of the returned device, the material was able to exit the device.
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Event Description
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It was reported by the customer that when placing the catheter in this patient, the head nurse found black extraneous substance near the valve in the catheter.No other information was provided.
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