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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 50 ML BD PLASTIPAK LUER-LOK SYRINGE

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BECTON DICKINSON, S.A. 50 ML BD PLASTIPAK LUER-LOK SYRINGE Back to Search Results
Catalog Number 300223
Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. "multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1808352, medical device expiration date: 2023-10-31, device manufacture date: 2018-08-14; medical device lot #: 1805360, medical device expiration date: 2023-04-30, device manufacture date: 2018-05-21; medical device lot #: 1811351, medical device expiration date: 2023-10-31, device manufacture date: 2018-11-05. " initial reporter phone #: unknown. 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 the coating of the syringe is very smooth so that the syringe cannot be handled properly in combination with sterile gloves with the 50 ml bd plastipak¿ luer-lok¿ syringe. The following information was provided by the initial reporter: the coating of the syringe is very smooth so that the syringe cannot be handled properly in combination with sterile gloves. This causes a disruption to the preparation process in the pharmaceutical preparation department. The print (graduation scale) is also considerably lighter in color than other previously used syringes. This concerns article v62. 300223. Batch numbers: 1805360/1811351/1808352.
 
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Brand Name50 ML BD PLASTIPAK LUER-LOK SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8470412
MDR Text Key147095936
Report Number3003152976-2019-00230
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300223
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 Received03/11/2019
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: 04/01/2019 Patient Sequence Number: 1
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