MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU PN RELION 31G X 6MM; 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	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 pn relion 31g x 6mm was unable to deliver insulin, and unable to prime.The following information was provided by the initial reporter: relion pharmacist and consumer called in.Consumer reported, no insulin flow when priming.Stated, he primes 2 to 3 units stated, no insulin flow when taking injection.Stated, he's using 2 or 3 pen needles to complete one injection.
Event or Problem Description
It was reported that the pn relion 31g x 6mm was unable to deliver insulin, and unable to prime.The following information was provided by the initial reporter: relion pharmacist and consumer called in.Consumer reported, no insulin flow when priming.Stated, he primes 2 to 3 units.Stated, no insulin flow when taking injection.Stated, he's using 2 or 3 pen needles to complete one injection.
Additional Manufacturer Narrative
H6: investigation: customer returned (4) sealed 6mm, 31g pen needles from lot # 0140337.Customer states that the insulin does not flow when priming.All returned pen needles were tested and all were able to expel properly without any observed defects.Lot#0140337 dhr was reviewed and no qn found.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: PN RELION 31G X 6MM
• 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: 12242878
• Report Number: 3014704491-2021-00051
• Device Sequence Number: 19873137
• 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: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: Other
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 320617
• Device Lot Number: 0140337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1