MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD 6MM RELION 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	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0248548, medical device expiration date: 2025-09-30, device manufacture date: 2021-03-04.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown, investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st 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.Lot#0248548 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 7 retention samples and no needle clog fail was found.No samples were returned for further investigation.Unconfirmed bd was not able to duplicate or confirm the customer¿s indicated failure mode based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
Event or Problem Description
It was reported that at least 2 bd 6mm relion pen needles were unable to prime.The following information was provided by the initial reporter: consumer reported no insulin flow when taking injection.Stated, she's been having the issues on and off for one year with different boxes but this is the first time reporting.

• Brand Name: BD 6MM RELION PEN NEEDLE
• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12906090
• Report Number: 3014704491-2021-00307
• Device Sequence Number: 4740019
• Product Code: FMI
• UDI-Device Identifier: 80382903206175
• UDI-Public: 80382903206175
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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 Catalogue Number: 320617
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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