MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU RELION® PEN NEEDLE; 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	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the relion® pen needle broke off after reinserting it.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "needle.Broke fell to floor.".
Additional Manufacturer Narrative
H6: investigation summary customer returned a single used 6mm, 31 gauge pen needle.The lot could not be confirmed as no teardrop label was provided.The patient end of the cannula was found to have broken off at its base.Saline from a test pen could still exit from the pen needle.Dhr was reviewed and there were not any qns or other events that could be related to this complaint.Based on the samples received, embecta was able to confirm the customer¿s indicated failure of a broken pen needle cannula.The root cause of the patient end of the cannula breaking is most likely unexpectedly high forces applied across the cannula during use.H3 other text : see h10.
Event or Problem Description
It was reported that the relion® pen needle broke off after reinserting it.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "needle.Broke fell to floor.".
Event or Problem Description
It was reported that the relion® pen needle was unable to deliver medication.The following information was provided by the initial reporter: consumer reported found 1 needle clogged while injecting.
Additional Manufacturer Narrative
H6: investigation summary: customer returned a single used 6mm, 31 gauge pen needle.The lot could not be confirmed as no teardrop label was provided.The patient end of the cannula was found to have broken off at its base.Saline from a test pen could still exit from the pen needle.Dhr was reviewed and there were not any qns or other events that could be related to this complaint.Based on the samples received, embecta was unable to confirm the customer¿s indicated failure of a needle clog.Root cause cannot be determined at this time as the issue is unconfirmed.
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the previously submitted report supplemental mdr 6987071 with mfr# for unable to deliver insulin/medication was sent in error.Therefore supplemental mdr 6987071 with mfr# is void as a result due to the incorrect mfr#.A new supplemental mdr for unable to deliver insulin/medication with the correct mfr# 3014704491-2022-00583 has been submitted, please reference correction supplemental mdr 10869404 with mfr# 3014704491-2022-00583 for your records.
Event or Problem Description
It was reported that the relion® pen needle was unable to deliver medication.The following information was provided by the initial reporter: consumer reported found 1 needle clogged while injecting.

• Brand Name: RELION® PEN NEEDLE
• 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 ; 8015296192
• MDR Report Key: 15795150
• Report Number: 3014704491-2022-00567
• Device Sequence Number: 14621394
• Product Code: FMI
• UDI-Device Identifier: 80382903206175
• UDI-Public: (01)80382903206175
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• 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,Followup,Followup
• Report Date (Section B): 09/26/2024

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: Lay User/Patient
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 320617
• Device Lot Number: 1232500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 01/19/2023; 09/26/2024
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/02/2023; 02/07/2023; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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