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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE WITH LUER SLIP

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE WITH LUER SLIP Back to Search Results
Catalog Number 990173
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2018
Event Type  malfunction  
Manufacturer Narrative
The date received by manufacturer has been used for this field. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that incorrect product was boxed with the bd plastipak¿ syringes with luer slips. There was no report of exposure, injury, or medical intervention.
 
Event Description
It was reported that incorrect product was boxed with the bd plastipak syringes with luer slips. There was no report of exposure, injury, or medical intervention.
 
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.
 
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Brand NameBD PLASTIPAK¿ SYRINGE WITH LUER SLIP
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key7813259
MDR Text Key118396927
Report Number3003916417-2018-00212
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 distributor,foreign,health pr
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990173
Device Lot Number7362886
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/24/2018 Patient Sequence Number: 1
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