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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE Back to Search Results
Catalog Number 306594
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one photo was provided.The photo shows the barrel flange damaged, therefore failure mode is verified.This type of damage most likely was induced by a process variation of the plunger rod label machine.Adjustments to the machine were done and preventive maintenance implemented.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 lot # 8019579 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: this type of damage most likely was induced by a process variation of the plunger rod label machine rationale: adjustments to the machine were done and preventive maintenance implemented.
 
Event Description
It was reported that bd posiflush¿ syringe was damaged.No serious injury or medical intervention was reported.Verbatim: "it was found flange broken after opening the unit package.".
 
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Brand Name
BD POSIFLUSH¿ SYRINGE
Type of Device
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8412503
MDR Text Key139583541
Report Number1911916-2019-00257
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2020
Device Catalogue Number306594
Device Lot Number8019579
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/25/2019
Initial Date FDA Received03/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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