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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 01/05/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 scale markings on the bd plastipak¿ syringe became discolored when they got wet.The following information was provided by the initial reporter, translated from german: "graduation on syringe discolors when it gets just a little wet.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 scale markings on the bd plastipak¿ syringe became discolored when they got wet.The following information was provided by the initial reporter, translated from german: "graduation on syringe discolors when it gets just a little wet.".
 
Event Description
It was reported that the scale markings on the bd plastipak¿ syringe became discolored when they got wet.The following information was provided by the initial reporter, translated from german: "graduation on syringe discolors when it gets just a little wet.".
 
Manufacturer Narrative
H.6.Investigation: pictures and a video have been received to perform investigation.Complaint involves 1ml syringes with reference 303172 and lot number 2106079.Customer reports ink of the scale of the syringe is not permanent.Dhr from lot 2106079 has been reviewed finding one quality notification related to marking process.Scale was not being printed completely and resulted in an incomplete scale.Once the failure was detected, mechanical team repaired the failure.Guiding part that introduced the syringes in the marking machine was not adjusted causing incomplete printings.Upon visual inspection of the picture received it can be seen two syringes with the scale not completely printed in the barrel of the syringe.Customer reports the scale is erased when it is wet, meaning the ink in not permanent.This defect is likely to be related to the misadjustments detected in the marking machine.According to information and picture received, the root cause of the non-conformance is related with a failure in the flaming system during marking process.
 
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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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13338050
MDR Text Key285243301
Report Number3003152976-2022-00019
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 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303172
Device Lot Number2106079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2021
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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