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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP PISTON SYRINGE Back to Search Results
Catalog Number 301033
Device Problems Break (1069); Volume Accuracy Problem (1675); Defective Device (2588); 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 is unknown; awareness date has been used for this field. There were multiple lot numbers reported to be involved. The information for each additional lot number is as follows: medical device lot #: 9312712. Medical device expiration date: 2024-10-31. Device manufacture date: 2019-11-08. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported while using bd syringe luer-lok¿ 30 ml bulk pack luer lock tip seven syringes had scale marking issues, one had foreign material contamination, one was scratched and damaged, and seven had a broken plunger. The following information was provided by the initial reporter: 7 syringes bad print,1 syringe with brown contamination, 1 syringe scratch at the bottom all around, 7 syringes broken plunger.
 
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Brand NameBD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13559496
MDR Text Key286776084
Report Number1911916-2022-00088
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number301033
Device Lot Number1215036
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2021
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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