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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ STERILE LUER SLIP 1ML SYRINGES; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ STERILE LUER SLIP 1ML SYRINGES; PISTON SYRINGE Back to Search Results
Catalog Number 303172
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Event Description
It was reported bd plastipak¿ sterile luer slip 1ml syringes had issues with volumetric accuracy.The following information was provided by the initial reporter: "the scaling of the 1ml tuberculin syringes is not correct.".
 
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
H6: investigation summary: two photos were provided to our quality team for investigation.Upon visual inspection, no marking defect can be observed on the syringes shown in the photo.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.During the barrel printing process, operators periodically verify the volume accuracy with a pass/non pass gauge.As the lot involved in this incident is unknown, a device history review cannot be performed.Given we were not able to observe any manufacturing defect, we cannot identify a root cause related to our manufacturing process at this time.
 
Event Description
It was reported bd plastipak¿ sterile luer slip 1ml syringes had issues with volumetric accuracy.The following information was provided by the initial reporter: "the scaling of the 1ml tuberculin syringes is not correct.".
 
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Brand Name
BD PLASTIPAK¿ STERILE LUER SLIP 1ML SYRINGES
Type of Device
PISTON 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14406753
MDR Text Key291723022
Report Number3003152976-2022-00212
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303172
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/25/2022
Initial Date FDA Received05/16/2022
Supplement Dates Manufacturer Received05/24/2022
Supplement Dates FDA Received06/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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