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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON 32 G X 4MM BD MICRO-FINE ULTRA¿ PEN NEEDLE INSULIN SYRINGE/NEEDLE

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BECTON DICKINSON 32 G X 4MM BD MICRO-FINE ULTRA¿ PEN NEEDLE INSULIN SYRINGE/NEEDLE Back to Search Results
Catalog Number 320425
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 09/13/2017
Event Type  Injury  
Manufacturer Narrative
Investigation summary: no samples or photos were returned for analysis. No dhr review can be carried out as lot number is unknown. Without a sample, no root cause can be determined. No corrective action is required as no defect can be confirmed.
 
Manufacturer Narrative
No lot # provided. Medical device expiration date: unknown. Device manufacture date: unknown. Initial reporter prefix: sister. Initial reporter phone#: (b)(6). (b)(4). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported, the needle of 32 g x 4mm bd micro-fine ultra¿ pen needle broke off in the patient while she administering insulin to herself. Magnesium sulfate was used to draw the broken needle out of the patient.
 
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Brand Name32 G X 4MM BD MICRO-FINE ULTRA¿ PEN NEEDLE
Type of DeviceINSULIN SYRINGE/NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6922688
MDR Text Key257086728
Report Number9616656-2017-00122
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320425
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2017
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: 10/06/2017 Patient Sequence Number: 1
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