MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU RELION PEN NEEDLES 6MM X 31 GAUGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	320617
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using relion pen needles 6mm x 31 gauge the needle broke.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported patient end is breaking whenever she injects in her stomach stated, sometimes patient end will break off in buttocks did not seek medical lot: 1308258 catalog: 320617 date of event: unknown.Samples: no cl.
Event or Problem Description
It was reported while using relion pen needles 6mm x 31 gauge the needle broke.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported patient end is breaking whenever she injects in her stomach stated, sometimes patient end will break off in buttocks did not seek medical.Lot: 1308258.Catalog: 320617.Date of event: unknown.Samples: no cl.
Additional Manufacturer Narrative
No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.H3 other text : see h10.

• Brand Name: RELION PEN NEEDLES 6MM X 31 GAUGE
• Common Device Name: 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 ; 8448235433
• MDR Report Key: 16709961
• Report Number: 3014704491-2023-00107
• Device Sequence Number: 20353630
• Product Code: FMI
• UDI-Device Identifier: 80382903206175
• UDI-Public: (01)80382903206175
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 320617
• Device Lot Number: 1308258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown