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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE 10ML LUER-LOK¿

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE 10ML LUER-LOK¿ Back to Search Results
Catalog Number 990172
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2018
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7362760; medical device expiration date: 2022-12-31; device manufacture date: 2017-12-28; medical device lot #: 7362762; medical device expiration date: 2022-12-31; device manufacture date: 2017-12-28; medical device lot #: 7362764; medical device expiration date: 2022-12-31; device manufacture date: 2017-12-28. (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd plastipak¿ syringe 10ml luer-lok¿ leaked, allowing air bubbles to enter the syringe while drawing blood. No serious injury or medical intervention was reported.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.
 
Event Description
It was reported that bd plastipak syringe 10ml luer-lok leaked, allowing air bubbles to enter the syringe while drawing blood. No serious injury or medical intervention was reported.
 
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Brand NameBD PLASTIPAK¿ SYRINGE 10ML LUER-LOK¿
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key7776686
MDR Text Key117016296
Report Number3003916417-2018-00201
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990172
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/13/2018 Patient Sequence Number: 1
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