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

Catalog Number	320617
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: exec summary: no samples were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.A review of the manufacturing records was performed and this is the 1st.Related complaint for inability to attach as intended on this lot #.No non-conformance's were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.Capa/sa: based on the above no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) are required at this time.Dhr review: a lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
Event or Problem Description
It was reported that 1 bd pn relion 31g x 6mm was difficult to operate.The following information was provided by the initial reporter: the consumer reported finding the new relion pen needles difficult to attach to the pen.

• Brand Name: PN RELION 31G X 6MM
• 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
• MDR Report Key: 12354354
• Report Number: 3014704491-2021-00092
• Device Sequence Number: 4739125
• Product Code: FMI
• UDI-Device Identifier: 00681131386807
• UDI-Public: 00681131386807
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 07/31/2025
• Device Catalogue Number: 320617
• Device Lot Number: 0184474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1