C.R. BARD, INC. (COVINGTON) -1018233 BARD 60CC PISTON IRRIGATION SYRINGE, INDIVIDUALLY SEALED WITH SYRINGE AND CAP, S; PISTON SYRINGE
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Catalog Number 750375 |
Device Problems
Gel Leak (1267); Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.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 device was not returned.
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Event Description
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It was reported that the piston syringe leaked.
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Event Description
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It was reported that the piston syringe leaked.
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Manufacturer Narrative
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The reported event was confirmed.Visual evaluation of the returned sample noted five total syringes.Three syringes (syringes #1-3) were returned within sealed original packaging.One syringe (syringe #4) was returned in an unsealed original packaging, and the last syringe (syringe #5) was returned in no original packaging.None of the syringes appeared to be used.The words "no good" were written on the returned packages.All syringes were removed from the packaging and inspected.Visual inspection of the syringes surfaces noted no obvious visible defects.Each syringe was filled with 50ml of a methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).No leaks were immediately noted from any of the syringes.Syringes were allowed to rest for 15 minutes.A finger was placed over the tapered opening and pressure was applied to the plunger.Leaks were visible from all five syringes.Dimensions of all five syringes were measured and found to be within specification.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: ¿bard® custom select 70cc piston syringe single use only.Sterile unless package is opened or damaged.Do not use if package is opened or damaged.Intended use: integral catheter tip - for catheter irrigation caution: secure tip tightly prior to use.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physican.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Bard is a registered trademark of c.R.Bard, inc.Or an affiliate.© 2005 c.R.Bard, inc.All rights reserved.¿.
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