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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK TIP SYRINGE PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK TIP SYRINGE PISTON SYRINGE Back to Search Results
Model Number 302832
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: it was reported there was a syringe scale error. To aid in the investigation, one sample in a sealed packaging blister and one photo were received for evaluation by our quality team. A visual inspection was performed and the scale marking is skewed. No other defects or imperfections were observed. The photo provided shows the sample received. It could be possible that the printing pad had a jam inducing the scale marking issue. A device history record review was completed for provided material number 302832, lot number 1026884. The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect. Verification of the printing process was performed. Settings and adjustments were found acceptable. The flow of products was good. Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported when using the bd luer-lok¿ tip syringe, the device experienced scale marking issues. The following information was provided by the initial reporter. The customer stated: syringe scale error.
 
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Brand NameBD LUER-LOK TIP SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12404821
MDR Text Key269266028
Report Number1911916-2021-00904
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903028321
UDI-Public30382903028321
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number302832
Device Catalogue Number302832
Device Lot Number1026884
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2021
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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