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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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that the bd plastipak¿ syringe plunger rod was bent. The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer uses this product for covid-19 vaccination. The customer found a bent plunger and reported this issue. ".
 
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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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12508503
MDR Text Key272726181
Report Number3003152976-2021-00620
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 distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? No
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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