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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGE; 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 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
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 the markings on the bd plastipak¿ syringe were light and the scale around the 0.2 mark was illegible.The following information was provided by the initial reporter, translated from japanese to english: "scale marking issue: the ink is faint and the scale (unit 0.2) is illegible.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-11-17.H6: investigation summary five syringes and photos received for investigation.Upon visual inspection of the samples, one syringe shows air bubbles in the barrel, this is a cosmetic defect and the product functionality is not affected.Regarding foreign matter, two different defects can be observed.Ink has been transferred to the unitary packaging in two devices and one particle has been found in the tip of one syringe.The particle found in the tip of the syringe is a black unremovable particle embedded in the material of the tip.One of the syringes it can be seen number 2 (0,2 in the scale) is partially erased but legible, this is a cosmetic defect that do not compromise the correct functionality of the device and it took place during marking process.A device history review was performed for lot 2008003, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.In the case of the ink transferred to the package, the defect may appear due to a failure in the ink drying process.Ink is dried with uv light that makes ink indelible.This defect is related with ink drying process.Embedded particle is associated with the molding process, due to the injection of burnt material generated during molding process.Scale marking issue-ink is not correctly transferred to the barrel due to a misalignment of the pad.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.
 
Event Description
It was reported that the markings on the bd plastipak¿ syringe were light and the scale around the 0.2 mark was illegible.The following information was provided by the initial reporter, translated from japanese to english: "scale marking issue: the ink is faint and the scale (unit 0.2) is illegible.".
 
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Brand Name
BD PLASTIPAK¿ SYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12555440
MDR Text Key274073489
Report Number3003152976-2021-00644
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
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 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303172
Device Lot Number2008003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2020
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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