C.R. BARD, INC. (COVINGTON) -1018233 SPIRIT® HYDROCOLLOID ADHESIVE SHEATH; MALE EXTERNAL CATHETER
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Model Number 35302 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
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.
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Event Description
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It was reported that the male external catheters were leaking and did not hold.Per follow-up information received from ibc on 25oct2022, stated that 54 catheters were received from the patient.The patient had been using male external catheters for over 7 years and there had been no problems with them so far.The patient was completely paralyzed, they were lying down, or used a specially adapted wheelchair and the carer of this patient reported the problem with catheters.Per notification from investigator on (b)(6) 2022, during sample evaluation strong adhesive was found while testing.
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Manufacturer Narrative
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The reported event is confirmed as manufacturing related.Visual evaluation noted 57 mec's were received with original closed packaging with no obvious defects.Samples were cut to the requirement width 1.00" +/- 0.05" for testing.All test samples did not meet the test specification range of 1.00-3.60 lbfs as strong adhesive was found during testing.Therefore, product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be operator error.The product was not used for patient diagnostic or treatment.The product was influenced by the reported event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as labelling would not prevent the reported event.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.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the male external catheters were leaking and did not hold.Per follow-up information received from ibc on 25oct2022, stated that 54 catheters were received from the patient.The patient had been using male external catheters for over 7 years and there had been no problems with them so far.The patient was completely paralyzed, they were lying down, or used a specially adapted wheelchair and the carer of this patient reported the problem with catheters.Per notification from investigator on 17nov2022, during sample evaluation strong adhesive was found while testing.
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