Catalog Number 392633 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that iag bc pro wing pnk 20ga x 1.0in was leaking and cracked at the hub.It was reported by customer that iv was inserted successfully in patient.Once inserted and hooked up to iv fluids, rn noticed iv was leaking under dressing, and then noticed iv hub was broken / cracked.
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Manufacturer Narrative
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Investigation results: received 2 broken catheter adapters of a 20gx1.00in insyte autoguard device from lot 3222374 for the investigation of this complaint.A photograph was also provided for investigation, which resembled the returned samples.A gross visual inspection of the returned samples shows two catheter adapters that are broken near the push tab.One adapter was missing the distal end that was connected to the catheter.It was present in the photo, but was not provided for investigation.The two parts of the other adapter were returned.The end with the catheter shows the same physical damage as the luer end.The fracture on this end is aligned with the perimeter of the wedge.The fracture is not smooth but rather jagged as some extreme force was apply to the unit tough a point of contact cannot be determined.The type of damage observed is most commonly observed in a u shape around the adapter.If existing crack is present, the adapter could come into 2 pieces during use.Based on the location and shape of the crack, the observed defect mostly likely originated during the zone five manufacturing process.Misalignment of the rotating gripers with respect to the pick and place grippers can caused a cracked adapter.The misalignment would cause contact before the adapter rotate operation is completed.Visual inspections for damaged/cracked adapters and leak testing are performed periodically per the sampling plan to mitigate the risk of this defect.Preventative maintenance (pm¿s) is also performed periodically to ensure proper functioning of the equipment.The manufacturing personnel were notified of this complaint.Investigation conclusion(s): the defect of catheter broke/separated after placement was confirmed.Probable root cause conclusion(s): manufacturing.
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Event Description
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No additional information.
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Search Alerts/Recalls
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