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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 20ML SYRINGE LUER-LOK TIP PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 20ML SYRINGE LUER-LOK TIP PISTON SYRINGE Back to Search Results
Model Number 302830
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2021
Event Type  malfunction  
Manufacturer Narrative
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: it was reported by the medical professional, the syringe did not seal correctly on the posiflows causing the medication to leak out onto the floor. To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team. A visual inspection was performed with a 10x magnifier lens and no defects or imperfections were observed. The luer dimension was verified finding it acceptable. A leakage test was performed and the sample passed. As the lot provided is 'unknown,' a device history record review could not be completed. Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a root cause could not be determined. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported when using the bd 20ml syringe luer-lok¿ tip, the device experienced leakage. The following information was provided by the initial reporter. The customer stated:   it was reported by the medical professional, the syringe did not seal correctly on our posiflows causing the medication to leak out onto the floor.   we received a medication in a 20 ml syringe today from pharmacy with the same "sun" picture next to the bd lab. The syringe did not seal correctly on our posiflows causing the medication to leak out onto the floor. Please send an alert out to your staff reminding them to be on the look out for these syringes again. They should not be used for our patients' medications. We were only made aware of the defective 3ml syringes with the sun versus the box on the product. There were never any issues reported with any other sizes. The 3ml that was defective was made in mexico and the plunger system for the mexican syringes is different. All the syringes available in our storeroom are made in the us. I'll reach out to bd again to confirm the plunger system for all sizes.
 
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Brand NameBD 20ML SYRINGE LUER-LOK TIP
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 Key12425573
MDR Text Key270631938
Report Number1911916-2021-00937
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number302830
Device Catalogue Number302830
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated by Manufacturer? Yes
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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