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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nano¿ 2nd gen pen needle was unable to prime.Report 2 of 2.The following was received from the initial reporter: consumer reported during the flow check of last 2 boxes 320122 found 10-15 pen needles each box that clogged.Informed caller of proper non patient end placement.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: after further evaluation of the complaint, it has been determined that the previously submitted report mdr # 9168991 was sent in error.Complaint captured under report mdr# 9230572 mfr#9616656-2023-01181.Mfr#: 9616656-2023-01157 is void as a result.
Event or Problem Description
It was reported that the bd nano¿ 2nd gen pen needle was unable to prime.Report 2 of 2.The following was received from the initial reporter: consumer reported during the flow check of last 2 boxes 320122 found 10-15 pen needles each box that clogged.Informed caller of proper non patient end placement.Verbatim: consumer reported during the flow check of last 2 boxes 320122 found 10-15 pen needles each box that clogged.Informed caller of proper non patient end placement.Dc lot # unknown - first box; lot # 3017796 current box ; catalog# 320122 = 2 boxes.Follow up from the verbatim = lot # unknown - first box; lot # 3017796 current box; catalog# 320122 = 2 boxes; date of event unknown; sample status discard.Hoping this helps dc; date of event unknown; sample status discard.

• 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: 18060395
• Report Number: 9616656-2023-01157
• Device Sequence Number: 7692568
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• 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,Followup
• Report Date (Section B): 11/30/2023

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: 3017796
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2023
• 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