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Model Number MR170126024S |
Device Problem
Leak/Splash (1354)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 09/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Nursing noticed swelling, patient pain, discomfort when picc used.Patient brought to vir for picc exchange.Upon removal the device was noted to have cracked.
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Manufacturer Narrative
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The device was returned for evaluation.A tear in the lumen is visible approximately 2 cm from the hub.This tear is consistent with the lumen bursting under pressure.Dried blood is visible inside the lumen just below the tear.If resistance was encountered when flushing the device or when injecting medications, the lumen could have undergone stresses it was not designed to withstand.A review of the manufacture records for the lot number reported revealed the lumen was manufactured according to specification with no non-conformances or abnormalities.As the device was implanted for 9 days prior to the occurrence, it is determined the root cause is most likely not manufacture related.A definitive root cause cannot be determined.The instructions for use (ifu) contains the following warnings and precautions: do not flush against resistance.Do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (14.5 psi).Only use infusion equipment complying with standards, which do not exceed a shut-off pressure of 1.0bar.Bolus injections should be slow and must not exceed the maximum bolus pressure of 1.2bar/900mmhg (17.4 psi).Small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.Device was used for treatment, not diagnosis.
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Search Alerts/Recalls
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