MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO ULTRA-FINE PEN NEEDLES, 32G X 4MM; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	320883
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 4198428, medical device expiration date: na, device manufacture date: 2014-09-24.Medical device lot #: 4302119, medical device expiration date: na, device manufacture date: 2014-12-03.Initial reporter state: address information was not able to be obtained, however, (b)(6).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 consumer found unopened bd nano" ultra-fine" pen needles, 32g x 4mm and the expiration dates were missing on shelf cartons.The following information was provided by the initial reporter: it was reported that consumer discovered there were no expiration dates on shelf cartons.Lot # 4302119 & 4198428.
Event or Problem Description
It was reported that consumer found unopened bd nano¿ ultra-fine¿ pen needles, 32g x 4mm and the expiration dates were missing on shelf cartons.The following information was provided by the initial reporter: it was reported that consumer discovered there were no expiration dates on shelf cartons.Lot # 4302119 & 4198428.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.

• Brand Name: BD NANO ULTRA-FINE PEN NEEDLES, 32G X 4MM
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 11675958
• Report Number: 9616656-2021-00400
• Device Sequence Number: 11640723
• Product Code: FMI
• UDI-Device Identifier: 00382903208838
• UDI-Public: 00382903208838
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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 Model Number: 320883
• Device Catalogue Number: 320883
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1