C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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It was reported "at approximately 1320 patient's line was flushed and positive blood return was present.Approximately ten minutes later, family called and blood had leaked through the distal end of the tubing attached to the needle just before the clave.The rn clamped the tube and flushed ns through and found a hole/crack near the needless connector.The rn then de-accessed and re-accessed the port." originally accessed 10/24/21 @ 1415, so 6 days in total no other treatment needed aside from new needle was running normal saline at 3ml/hr when leaking discovered no infiltration or extravasation noted.
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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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was confirmed and the cause is currently under investigation.The product returned for evaluation was one 20ga x 0.75" powerloc max saefty infusion set.The returned product sample was evaluated and the following observations were made: the fracture surfaces of the damage contained striation-like patterns, tear patterns and buckling which were indicative of flexural fatigue based material failure.While repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event, it appeared that additional unidentified factors also contributed.The device is a supplied component and the supplier has been notified of this event.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported "at approximately 1320 patient's line was flushed and positive blood return was present.Approximately ten minutes later, family called and blood had leaked through the distal end of the tubing attached to the needle just before the clave.The rn clamped the tube and flushed ns through and found a hole/crack near the needless connector.The rn then de-accessed and re-accessed the port." originally accessed (b)(6) 21 @ 1415, so 6 days in total.No other treatment needed aside from new needle.Was running normal saline at 3ml/hr when leaking discovered.No infiltration or extravasation noted.
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