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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ Back to Search Results
Catalog Number 305959
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 01/31/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one used 10ml sample without blister was received by our quality team for evaluation. Upon visual inspection of the used sample received, it can be verified that the stopper was assembled incorrectly to the plunger. The stopper was disassembled observing the plunger rod was broken causing the stopper to be assembled incorrectly. Dhr of lot 1705011p has been reviewed not finding any annotation or deviation regarding the alleged defect. A device history record review found no non-conformances associated with this issue during production of this batch. The areas where pieces run in manufacturing area are protected to avoid damage on product. Final products for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures. The root cause of this incident was related to the damage on the plunger rod causing the stopper to be incorrectly assembled. A project has been opened to further investigate this defect and the appropriate personnel have been notified. Investigation conclusion: the areas where pieces run in manufacturing area are protected to avoid damage on product. Final products for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures. Project#(b)(4)is open to investigate and reduce the occurrence of this defect. The incident is reported to area manager. Defect: damaged plunger which causes stopper wrong assembled the areas where pieces run in manufacturing area are protected to avoid damage on product. Final products for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures. Sub-process visual inspection functional inspection injection 2 injections per shift n/a printing 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift once in the first pallet and once in last pallet of the lot assembly 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift once in the first pallet and once in last pallet of the lot primary packaging 24 advance-step (with product) per hour, after any intervention in the equipment, and once at the beginning of the shift. Once in the first pallet and once in last pallet of the lot secondary packaging 1 shelf-package per pallet n/a project#(b)(4) is open to investigate and reduce the occurrence of this defect. The incident is reported to area manager root cause description: the stopper is disassembled observing the plunger rod is broken. So the damage on the plunger rod is the cause the stopper is not correctly assembled. Rationale: based on an evaluation of severity and frequency it was determined that no capa is required at this time, according to procedure (b)(4).
 
Event Description
It was reported that the stopper of the bd plastipak¿ hypodermic syringe luer lok¿ we bent. Found before use. There was no report of injury or medical intervention.
 
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Brand NameBD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿
Type of DeviceHYPODERMIC SYRINGE
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
8015652845
MDR Report Key7286512
MDR Text Key100900002
Report Number3003152976-2018-00044
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305959
Device Lot Number1705011P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2017
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: 02/21/2018 Patient Sequence Number: 1
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