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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, 25 G X 5/8 IN RETRACTING NEEDLE HYPODERMIC SYRINGE WITH NEEDLE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE, 25 G X 5/8 IN RETRACTING NEEDLE HYPODERMIC SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 305310
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Fda notified yes: the initial reporter also notified the fda november 2017 via medwatch # (b)(4). Results: a sample was not returned for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
Event Description
It was reported after administering vaccinations using an bd integra¿ syringe, 25 g x 5/8 in retracting needle, the needle failed to retract when the plunger was pushed. There was no report of injury or medical intervention.
 
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Brand NameBD INTEGRA¿ SYRINGE, 25 G X 5/8 IN RETRACTING NEEDLE
Type of DeviceHYPODERMIC SYRINGE 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 Key7185807
MDR Text Key97665209
Report Number1911916-2017-00418
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,use
Reporter Occupation
Type of Report Initial
Report Date 12/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number305310
Device Lot NumberUNKNOWN
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 Received12/18/2017
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: 01/12/2018 Patient Sequence Number: 1
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