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 Problems
Pain (1994); Chemical Exposure (2570)
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Event Date 01/06/2023 |
Event Type
malfunction
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Event Description
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It was reported by the customer, patient powerloc max has a crack in the distal end (long-end) that had a cap over it.Staff are working to softly loop the tubing to her chest and use an ace wrap to hold it in place (keep in mind she would have this needle, flowed by a male/female equashield safety connector, and the chemo tubing.) additional information received 2/15/2023: transparent dressing was used to secure the line.Patient was receiving continuous chemotherapy infusions, incident caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedure to re-access.
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) review is not possible, as no manufacturing batch number has been provided by the complainant.
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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, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a crack in the tubing was confirmed and the cause is currently under investigation.The product returned for evaluation was 20g x ¾¿ w/y-site powerloc max infusion set.The returned product sample was evaluated and the following observations were made: a split was observed in the tubing where it connects to the distal luer adapter.The fracture surfaces of the damage contained striation-like patterns which were indicative of flexural fatigue based failures, which may have been a contributing factor to the extension tubing damage.Repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event; however, it appeared that additional unidentified factors also contributed.The device is a supplied component and the supplier has been notified of this event.
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Event Description
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It was reported by the customer, patient powerloc max has a crack in the distal end (long-end) that had a cap over it.Staff are working to softly loop the tubing to her chest and use an ace wrap to hold it in place (keep in mind she would have this needle, flowed by a male/female equashield safety connector, and the chemo tubing.) additional information received on 2/15/2023: transparent dressing was used to secure the line.Patient was receiving continuous chemotherapy infusions, incident caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedure to re-access.Additional information on 3/6/2023: "patient was receiving continuous chemotherapy infusions during this time, d545 with 20 kcl, cytarabine, daunorubicin, zofran incidence caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedures to reaccess.".
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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 manufacturer has received the sample and will evaluate.Results are expected soon.
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Event Description
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It was reported by the customer, patient powerloc max has a crack in the distal end (long-end) that had a cap over it.Staff are working to softly loop the tubing to her chest and use an ace wrap to hold it in place (keep in mind she would have this needle, flowed by a male/female equashield safety connector, and the chemo tubing.) additional information received 2/15/2023 transparent dressing was used to secure the line.Patient was receiving continuous chemotherapy infusions, incident caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedure to re-access.Additional information 3/6/2023: "patient was receiving continuous chemotherapy infusions during this time, d545 with 20 kcl, cytarabine, daunorubicin, zofran incidence caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedures to reaccess.".
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