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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE

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BECTON DICKINSON SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE Back to Search Results
Model Number 328468
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2021
Event Type  malfunction  
Manufacturer Narrative
"unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported that a syringe 0. 5ml 31ga 8mm ufii 10bag 500cs was damaged before use. The following was reported by the initial reporter: "it was reported that the syringe had a defective plunger, the thumb press is missing. Verbatim: from phone call on (b)(6) 2021, 17:07:43: consumer stated, removed needle shield prior to injection and found needle missing. Stated, found damaged plungers; thumb press was missing. Stated, his wife discarded samples when he was in hospital, just got out today, (unrelated to complaint). Samples: no. (b)(4). Pir attached to file. Information from email copied. Email received on 2021-03-09, 13:35:09. Customer called in to report that about 90% of his box of insulin syringes had a defective plunger. The part where his thumb would be placed was missing. He stated that he has the defective syringes in his sharps container. ".
 
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Brand NameSYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11607228
MDR Text Key268796235
Report Number2243072-2021-00925
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328468
Device Catalogue Number328468
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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