MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU PN RELION 31G X 6MM 3B; PEN NEEDLE

Catalog Number	320617
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 2nd complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Investigation conclusion: lot#0140339 dhr was reviewed and no qn found.Manufacture records were reviewed, no abnormality was found.Pen needle product has 100% clog test in flowguru station, and defect part will be rejected by flowguru station automatically.Clog test was conducted on 7pcs retention samples and all no needle clog fail found.No samples were returned for further investigation.Base on investigation above, the certain cause cannot be concluded at the moment.
Event or Problem Description
It was reported that the pn relion 31g x 6mm 3b was unable to deliver insulin.The following information was provided by the initial reporter: consumer reported finding 1 pen needle to clog during injection.Does not complete flow check before injections.Changed this pen needle from baslagar pen and completed injections with another pen needles.

• Brand Name: PN RELION 31G X 6MM 3B
• Common Device Name: PEN 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 Key: 12170399
• Report Number: 3014704491-2021-00039
• Device Sequence Number: 1533469
• Product Code: FMI
• UDI-Device Identifier: 80382903206175
• UDI-Public: 80382903206175
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: 05/31/2025
• Device Catalogue Number: 320617
• Device Lot Number: 0140339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1