Catalog Number 515302 |
Device Problems
Leak/Splash (1354); Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1011101; medical device expiration date: 2022-04-30; device manufacture date: 2019-01-10; medical device lot #: 1011464; medical device expiration date: 2022-08-31; device manufacture date: 2019-02-28; medical device lot #: unknown; medical device expiration date: unknown; device manufacture date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd phaseal¿ secondary set c61 is allowing air bubbles to form in the tube.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: phaseal c-61 is leaking (drops are coming from the plastic part above the tubing, and nurses have had drops on them).Even if there are no drops, the hoses are getting air from somewhere and the air bubbles make it impossible to administer the infusion via pumps.So this is a complaint on two problems wit c61: leakage 2.Air bubbles in the tubing.Customer will not use c61 until we have an explanation and solution (replacement product?).Problem occured 15 times.
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Manufacturer Narrative
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Investigation: dhr review was done and no issues were reported during production of this lots.No sample received for this complaint, picture was provided.Ct scan was done on leaking sample which was segregated during production.After this scan additional tests were done on spike component and concentricity of lower part of spike component caused molding deficit on one side of component.Capa#891423 was initiated.
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Event Description
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It was reported that bd phaseal¿ secondary set c61 has leakage and caused chemotherapeutic medication exposure.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: phaseal c-61 is leaking (drops are coming from the plastic part above the tubing, and nurses have had drops on them).Even if there are no drops, the hoses are getting air from somewhere and the air bubbles make it impossible to administer the infusion via pumps.So this is a complaint on two problems wit c61: 1.Leakage 2.Air bubbles in the tubing.Customer will not use c61 until we have an explanation and solution (replacement product?) problem occured 15 times.
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Manufacturer Narrative
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The following fields have been updated with corrections: short description: pr# 856106, leakage and chemotherapeutic medication exposure (04/11).Describe event or problem: it was reported that bd phaseal¿ secondary set c61 has leakage and caused chemotherapeutic medication exposure.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: phaseal c-61 is leaking (drops are coming from the plastic part above the tubing, and nurses have had drops on them).Even if there are no drops, the hoses are getting air from somewhere and the air bubbles make it impossible to administer the infusion via pumps.So this is a complaint on two problems wit c61: 1.Leakage 2.Air bubbles in the tubing.Customer will not use c61 until we have an explanation and solution (replacement product?) problem occured 15 times.Type of reportable events: serious injury.
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Event Description
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It was reported that bd phaseal¿ secondary set c61 has leakage and caused chemotherapeutic medication exposure.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: phaseal c-61 is leaking (drops are coming from the plastic part above the tubing, and nurses have had drops on them).Even if there are no drops, the hoses are getting air from somewhere and the air bubbles make it impossible to administer the infusion via pumps.So this is a complaint on two problems wit c61: 1.Leakage 2.Air bubbles in the tubing.Customer will not use c61 until we have an explanation and solution (replacement product?) problem occured 15 times.
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Search Alerts/Recalls
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