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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE PLASTIPAK 20ML LL S/SU

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BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE PLASTIPAK 20ML LL S/SU Back to Search Results
Catalog Number 990687
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/23/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8289583; medical device expiration date: 2023-10-31; device manufacture date: 2018-10-16; medical device lot #: 8225769; medical device expiration date: 2023-08-31; device manufacture date: 2018-08-13. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that during use of the syringe plastipak 20ml ll s/su the syringe is not properly threaded in the introducers, it is difficult to attach the syringe. Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: the syringe is not properly threaded in the introducers, it is difficult to attach the syringe. Customer informed two possible batches involved: 8289583 e 8225769. Consider both in the investigation.
 
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Brand NameSYRINGE PLASTIPAK 20ML LL S/SU
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer (Section G)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8579412
MDR Text Key145960170
Report Number3003916417-2019-00221
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990687
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/03/2019 Patient Sequence Number: 1
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