MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	320122
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd nano¿ 2nd gen pen needle one needle was unable to prime.The following was received from the initial reporter: stated, she primed 2 units stated, she tried a second pen needle that worked when priming.Consumer reported bd ultra fine pen needle nano lot # 3101673 found 1 pen needle clog - during flow check.
Additional Manufacturer Narrative
H.3.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 while using the bd nano¿ 2nd gen pen needle one needle was unable to prime.The following was received from the initial reporter: stated, she primed 2 units stated, she tried a second pen needle that worked when priming.Consumer reported bd ultra fine pen needle nano lot # 3101673 found 1 pen needle clog - during flow check.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: h.6.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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 05-jan-2024.H.6 investigation summary: samples were received and an investigation was performed.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.Embecta was able to duplicate or confirm the indicated issue as bent cannula npe.Based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd nano¿ 2nd gen pen needle one needle was unable to prime.The following was received from the initial reporter: stated, she primed 2 units stated, she tried a second pen needle that worked when priming.Consumer reported bd ultra fine pen needle nano lot # 3101673 found 1 pen needle clog - during flow check.

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18188310
• Report Number: 9616656-2023-01204
• Device Sequence Number: 12427936
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2024

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 Catalogue Number: 320122
• Device Lot Number: 3101673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 03/07/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/15/2023; 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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