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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE SYRINGE WITH NEEDLE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 305310
Device Problems Retraction Problem (1536); Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation results: no photos or samples were received in the (b)(4) plant for evaluation therefore failure mode could not be verified and root cause could not be determined. A device history record review found no non-conformance's associated with this issue during production of this batch. Capa not necessary.
 
Manufacturer Narrative
The initial reporter also notified the fda on 10/11/2017 via medwatch #5072679. A sample is not available for evaluation. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that after use, a bd integra¿ syringe with retracting needle did not retract completely which resulted in a patient receiving a superficial scratch on her thigh when the syringe was being pulled away. The tip of the needle was still outside the hub of the syringe. There was no report of exposure to mucous membranes, injury or medical interventions.
 
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Brand NameBD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
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 Key7070416
MDR Text Key270337388
Report Number1911916-2017-00360
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2021
Device Catalogue Number305310
Device Lot Number6048798
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2016
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: 11/30/2017 Patient Sequence Number: 1
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