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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 302055
Device Problems Break (1069); Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
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 a broken plunger rod (3 occurrences), foreign matter (1 occurrence) and scale marking issues (8 occurrences) were present on the bd plastipak¿ syringe. The following information was provided by the initial reporter, translated from (b)(6) to english: 8 syringes with ink contamination. 1 syringe with white dot on rubber. 3 syringes with broken thumb pressure.
 
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 a broken plunger rod (3 occurrences), foreign matter (1 occurrence) and scale marking issues (8 occurrences) were present on the bd plastipak¿ syringe. The following information was provided by the initial reporter, translated from (b)(6) to english: 8 syringes with ink contamination. 1 syringe with white dot on rubber. 3 syringes with broken thumb pressure.
 
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Brand NameBD PLASTIPAK¿ SYRINGE
Type of DevicePISTON 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 Key13552854
MDR Text Key286002698
Report Number3003152976-2022-00068
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K182589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number302055
Device Lot Number2107066
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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