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Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the syringes were cracked in the foley kits.It happened with 3 different patients.First 2 patients were unknown, the 3rd happened on (b)(6) 2023.Per follow up via email on 05dec2023, it was reported that the crack were on the barrel and the plunger of the syringe.Sterile water was being used in the syringe, the cracks caused a leak.Nursing staff caught the issues before issue affected patient.Another syringe was utilized.
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Event Description
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It was reported that the syringes were cracked in the foley kits.It happened with 3 different patients.First 2 patients were unknown, the 3rd happened on (b)(6) 2023.Per follow up via email on 05dec2023, it was reported that the crack were on the barrel and the plunger of the syringe.Sterile water was being used in the syringe, the cracks caused a leak.Nursing staff caught the issues before issue affected patient.Another syringe was utilized.Per follow up via email on 10jan2024, it was reported that all syringes were from the same lot nghv0306.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the syringes were cracked in the foley kits.It happened with 3 different patients.First 2 patients were unknown, the 3rd happened on (b)(6) 2023.Per follow up via email on 05dec2023, it was reported that the crack were on the barrel and the plunger of the syringe.Sterile water was being used in the syringe, the cracks caused a leak.Nursing staff caught the issues before issue affected patient.Another syringe was utilized.Per follow up via email on 10jan2024, it was reported that all syringes were from the same lot nghv0306.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "defective components from supplier".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." section a through f - the information provided by bard 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 bard.
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Search Alerts/Recalls
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