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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

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 20ML SYRINGE LUER-LOK TIP Back to Search Results
Catalog Number 302830
Device Problems Contamination (1120); Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: four samples and 2 photos were received for evaluation. On the top of the packaging blister there is a silver splice. This splice didn¿t allow the package to seal the bottom and top web. The silver splice came with the bottom web. Two photos provided show the described defect from the samples. Failure mode is verified. The silver splice is the end of the bottom web and was inadvertently used in the final row of packaging. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. A device history record review was completed with zero defects found. No quality notifications were written for this batch, nor for the associated assembly batches. Investigation conclusion: this is the 1st complaint for the lot# 8332503 for the same defects or symptoms. There was no documentation of issues for the complaint of batch #8332503 during this production run. Root cause description: the silver splice is the end of the bottom web and was inadvertently used in the final row of packaging.
 
Event Description
It was reported that 4 bd 20ml syringe luer-lok¿ tips had silver strip along the end of the plastic wrapping. It appears to be the beginning or end of the plastic sheet. The packaging is not sealed at the top rendering the syringes non-sterile and unusable.
 
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Brand NameBD 20ML SYRINGE LUER-LOK TIP
Type of DeviceSYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8396855
MDR Text Key138384569
Report Number1911916-2019-00245
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
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 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302830
Device Lot Number8332503
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/06/2019 Patient Sequence Number: 1
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