The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.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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Received 1 used toomey syringe with the original unit packaging.Visual inspection noted that the tip was connected to the syringe and no obvious defects were observed.The following functional test was performed: inflate balloon: take an in house catheter to inflate the balloon (10cc).Connect the luer adapter to syringe.Fill the syringe with 10cc of water.Proceed to inflate the balloon, with the syringe.Catheter irrigation: take an in house catheter to be irrigated (70cc).Connect the toomey adapter to syringe tip.Fill the syringe with 70cc of water.Proceed to irrigate the catheter with the syringe.During both tests no discrepancies were found.The adapters (luer and toomey) stayed attach to the syringe.The following dimensional test was performed: inner diameter = 0.301in (specification is 0.303 in ± 0.005 in).Toomey adapter: inner diameter =0.465 in (specification is 0.460 in ± 0.005 in).Outer diameter tip = 0.253 in (specification is 0.250 in ± 0.005 in).Syringe barrel : upper o.D.= 0.473 in (specification 0.472 in ± 0.005 in).Lower o.D.= 0.501 in (specification 0.504 in ± 0.005 in).The sample dimensions were found to be within specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was unconfirmed as the device met all specifications.The instructions for use state the following: "three syringe tips are intended for use as follows: integral toomey tip - resectoscope irrigation.Catheter tip - for catheter irrigation.1 luer adapter (for foley catheter inflation).Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: secure tip tightly prior to use.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge." (b)(4).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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