C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problems
Defective Component (2292); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2023 |
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 batch history review (bhr) of regt3425 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported, crack in clear t-port which is what the stylet goes through, picc had to be exchanged for a new one.No other information was provided.
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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.
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Event Description
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It was reported, crack in clear t-port which is what the stylet goes through, picc had to be exchanged for a new one.No other information was provided.
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Event Description
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It was reported, crack in clear t-port which is what the stylet goes through, picc had to be exchanged for a new one.No other information was provided.
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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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged t-lock assembly was confirmed; however, the root cause was not identified.The product returned for evaluation was one 5fr d/l powerpicc catheter.The sample was received with an inlaid stylet and attached t-lock assembly.The wire had been manipulated within the t-lock septum and a sharp bend was observed in the wire just proximal of the t-lock.The septum appeared concave at the wire exit site and was partially dislodged from the t junction.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed at the t-lock assembly due to the dislodgement.Microscopic inspection of the sample confirmed deformation and dislodgement of the t-lock assembly septum.The t-lock assembly septum was easily fully detached from the t-lock during gentle manipulation.The shrink tubing was also easily manipulated.Deformation and dislocation of the t-lock septum was observed and resulted in leakage; however, the cause of that deformation was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The bend in the wire suggested that manipulation may have contributed, which may have occurred prior to or during attempted use.H3 other text : evaluation findings are in section h.11.
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