C.R. BARD, INC. (BASD) -3006260740 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Catalog Number 6F118100 |
Device Problems
Defective Component (2292); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us but is similar to the powerglide pro products that are cleared in the us.The pro code and 510k number for the powerglide pro products is identified.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (04/2022).Device not returned.
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Event Description
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It was reported that prior to a peripheral venous catheter placement, the catheter allegedly twisted at its distal end while opening the kit.There was no patient contact.
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Event Description
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It was reported that prior to a peripheral venous catheter placement, the catheter twisted at its distal end while opening the kit.It was stated there was no patient contact.
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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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a twisted catheter was inconclusive due to the sample condition.One powerglide pro deployment system was returned for investigation.The catheter had been removed from the needle and was not returned for investigation.The safety mechanism was engaged over the needle tip.The distal tip of the guidewire was observed within the distal end of the safety mechanism.Kinks were observed in the guidewire within the handle at the proximal end of the needle.It appears that the guidewire was not fully extended from the needle due to the kinking, which may have been a factor in the reported event.The cause of the kinking of the wire and twisting of the catheter may have been advancement against resistance; however, the exact mechanism of damage could not be determined from the returned sample.A lot history review (lhr) of reen3225 showed no other similar product complaint(s) from this lot number.
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Search Alerts/Recalls
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