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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU PN RELION 31G X 6MM 3B TW; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU PN RELION 31G X 6MM 3B TW; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320617
Device Problems Misconnection (1399); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 2 bd pn relion 31g x 6mm 3b tw needles were difficult to operate or the needle did not detach.The following information was provided by the initial reporter :   it was reported by the consumer the pen needles do not fit on the insulin pen and are difficult to pull off once the injection is completed.  date of event : unknown.Samples : yes.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 7/13/2021.H6: investigation: customer returned (50) open 6mm, 31g relion pen needles without the tear drop label or inner shield in the shelf carton from lot # 0140338 along with (1) lanuts pen and (1) lilly pen.Customer states that the pen needles do not fit on the insulin pen and are difficult to pull off once the injection is completed.Thirty out of 50 returned pen needles were tested and all were able to properly and securely attach and properly and easily detach from a pen without any observed defects.Dhr was reviewed for lot# 0140338 and no qn found.Root cause cannot be determined at this time as the issue is unconfirmed.
 
Event Description
It was reported that 2 bd pn relion 31g x 6mm 3b tw needles were difficult to operate or the needle did not detach.The following information was provided by the initial reporter :   it was reported by the consumer the pen needles do not fit on the insulin pen and are difficult to pull off once the injection is completed.  date of event: unknown.Samples: yes.
 
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Brand Name
PN RELION 31G X 6MM 3B TW
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
MDR Report Key12229943
MDR Text Key266731586
Report Number3014704491-2021-00049
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
PMA/PMN Number
K162516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number320617
Device Lot Number0140338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Date Manufacturer Received07/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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