Model Number 384539 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problem
Laceration(s) (1946)
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Event Type
malfunction
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Manufacturer Narrative
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It is unknown if the sample will get returned or not.Argon has not received the sample for investigation yet.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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(b)(4).¿event description: 26 g 1.9 fr picc, lot #: 11437171.Picc noted to be split and leaking at proximal site where catheter increases in size ("skinny to fat" connection).This resulted in picc line being pulled and patient needing piv.Piv was placed with 3 attempts, final attempt using ultrasound guidance.Contributing factors: this rn ((b)(6)) redressed picc line dressing with charge-trained resource rn at approx 1600.The reason for dressing change was old dressing soiled with stool.Appropriate reinforcement was placed on picc line utilizing cut flexitrack.Then, patient was removed from bed and placed in mother's arms for approx.2 hours.While mother was holding patient, occlusion alarm noted from alaris pump x 2 (occlusion - patient side).Both times, this rn repositioned patient and patient line, restarted pump, and successfully cleared alarms.This rn did manually flush picc line after second alarm with approx 2 cc ns flush.Line flushed easily and with no resistance.When patient was placed back in bed, dressing noted to have clear fluid underneath.This rn and another rn took down the dressing, called an np to investigate.The leakage site was identified and the line was pulled.¿.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, there was no sample returned for this complaint.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining the definite root cause of the breakage and a corrective action is not possible.There have been no other complaints regarding this issue with this lot number.If a sample is returned at a future date, this complaint will be reopened for further evaluation at that time.
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Event Description
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(b)(4).¿event description: 26 g 1.9 fr picc lot: 11437171.Picc noted to be split and leaking at proximal site where catheter increases in size ("skinny to fat" connection).This resulted in picc line being pulled and patient needing piv.Piv was placed with 3 attempts, final attempt using ultrasound guidance.Contributing factors.This rn (b)(6) redressed picc line dressing with charge-trained resource rn at approx 1600.The reason for dressing change was old dressing soiled with stool.Appropriate reinforcement was placed on picc line utilizing cut flexitrack.Then, patient was removed from bed and placed in mother's arms for approx.2 hours.While mother was holding patient, occlusion alarm noted from alaris pump x 2 (occlusion - patient side).Both times, this rn repositioned patient and patient line, restarted pump, and successfully cleared alarms.This rn did manually flush picc line after second alarm with approx 2 cc ns flush.Line flushed easily and with no resistance.When patient was placed back in bed, dressing noted to have clear fluid underneath.This rn and another rn took down the dressing, called an np to investigate.The leakage site was identified and the line was pulled.¿.
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Search Alerts/Recalls
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