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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD ¿ PRE-FILLED NORMAL SALINE SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD ¿ PRE-FILLED NORMAL SALINE SYRINGE Back to Search Results
Catalog Number 306559
Device Problems Activation, Positioning or SeparationProblem (2906); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Fda notified: the initial reporter also notified the fda (b)(4). Investigation summary: as no samples or pictures were received for evaluation, our quality team was unable to confirm the reported defect of pump incompatibility. As no lot number was provided, a device history record review could not be completed. It is important to note that the bd franklin flush syringe (product code 306500) does not claim pump compatibility. Bd does not recommend use of this product with a pump. The current controls for syringes including incoming, in-process, and final inspections will remain in place. Investigation conclusion: complaint: pump occlusion and plunger movement difficult. No sample received. A dhr could not be performed as no lot # was provided. There have been zero prior compalints for plunger movement difficult in the past year. There have been similar complaints for "pump alarm/occlusion/incompatibility" within the past year. Note: the bd franklin flush syringe does not claim pump compatibility. Bd does not recommend use of this product with a pump. Bd was not able to duplicate or confirm the customer's indicated failure mode. The customer's indicated failure mode of pump alarm/occlusion and plunger movement could not be confirmed as no sample or photo was provided. Based on the investigation, root cause was not found. No formal corrective action is required at this time. The current controls for syringes including incoming, in-process and final inspections will remain in place. Root cause description based on the investigation, root cause was not found.
 
Event Description
It was reported that during use a bd ¿ pre-filled normal saline syringe malfunctioned as " the medfusion syringe pumps are having trouble recognizing the loml bd pre- filled flushes. The pump will read "invalid syringe size" and reseating the flush does not work. The change in the plunger when posiflush came out caused increased drag and thereby increased pressure upon deployment of the fluid. " there was no report of exposure, injury or medical intervention needed.
 
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Brand NameBD ¿ PRE-FILLED NORMAL SALINE SYRINGE
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
8015652845
MDR Report Key7583730
MDR Text Key110876425
Report Number1911916-2018-00318
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number306559
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/08/2018 Patient Sequence Number: 1
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