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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU RELION PEN NEEDLES 4MM X 32 GAUGE (5/32" X 0.23MM) PEN NEEDLES 50 COUNT; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU RELION PEN NEEDLES 4MM X 32 GAUGE (5/32" X 0.23MM) PEN NEEDLES 50 COUNT; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320618
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using relion pen needles 4mm x 32 gauge (5/32" x 0.23mm) pen needles 50 count the needle didn't properly attach.There was no report of patient impact.The following information was provided by the initial reporter: reported when placed the non patient end onto pen, the needle would not attach properly to pen removed it.
 
Event Description
It was reported while using relion pen needles 4mm x 32 gauge (5/32" x 0.23mm) pen needles 50 count the needle didn't properly attach.There was no report of patient impact.The following information was provided by the initial reporter: reported when placed the non patient end onto pen, the needle would not attach properly to pen removed it.
 
Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Tested 7pcs retention samples of thread function and np end appearance, all results passed.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
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Brand Name
RELION PEN NEEDLES 4MM X 32 GAUGE (5/32" X 0.23MM) PEN NEEDLES 50 COUNT
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH  215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH   215126
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15511320
MDR Text Key306361121
Report Number3014704491-2022-00448
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320618
Device Lot Number1282545
Was Device Available for Evaluation? No
Date Manufacturer Received10/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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