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.
|
The reported event was confirmed as supplier related due to the supplier product dimensions being out of specification.The visual evaluation of the returned sample noted 2 tooney syringes, one opened, used syringe without its original packaging, and one unused with a luer tip adaptor (cm50005) inside the barrel, within original packaging.The syringes were filled with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).The used syringe's tooney adapter (cm1687) outer diameter was 0.2690", which was found out of the specification of 0.250"±0.005", while its inner diameter was 0.1865", which was out of the specification of 0.192"±0.005".The unused syringe's tooney adapter (cm1687) outer diameter was 0.2670" which was out of the specification of 0.250"±0.005", while the tip inner diameter was 0.1885", which was within the specification of 0.192"±0.005".The luer tip adaptor's (cm50005) inner diameter at the larger end was 0.2995", which was found within the specification of 0.303"±0.005".The tip was also measured at the smaller end to be 0.074", which was also within the specification of 0.070".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: "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.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.".
|