The information provided by bard 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 bard.The initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of guidewire complications was confirmed and the cause appeared to be use-related.The product returned for evaluation was two 18ga x 10cm powerglide pro midline catheter assemblies.Both samples were received with the safety mechanisms engaged and the catheters detached.Blood residues were observed throughout both samples.Both guidewires were disengaged from the advancers.Both guidewires appeared to be intact.Microscopic inspection of the first sample (sample 1) revealed a kink in the guidewire near the weld tip.Inspection of the needle revealed mechanical damage along the proximal edge of the bevel.Microscopic inspection of the second sample (sample 2) revealed superficial scoring marks on the coupler.The usage residues, guidewire kink and marks on the coupler were consistent with the guidewire being advanced against resistance during attempted use.Such resistance can occur if guidewire advancement into tissue is attempted and can result in guidewire damage and detachment from the advancer.A lot history review (lhr) of reby2533 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby2533) have been reported from the same facility.
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It was reported that the powerglide needle was inserted in the patient's vein, then the "wire wouldn't allow them to advance, it was like it was locked." it happened twice.On 5/2/2018 - returned samples have blood residue, indicating use on a patient.Both samples have guidewires that were dislodged from the coupler and one guidewire was found to be kinked at the tip.This report address the second device (sample 2).
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