MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEN NDL 32G 4MM; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	320883
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
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 pen ndl 32g 4mm was unable to deliver insulin/medication.The following information was provided by the initial reporter: consumer reported ---finding from this box 1 out of every 2-3 pen needles clog during injection verified the lot number and obtained the item # from the box.This user is also a doctor who has medical practice at home address.Reviewed placement of pen needles onto the pen and to complete a flow check with each injection.Consumer resistant to completing this process.Lot #: 8360678.Catalog#: 320883.Date of event: unknown.
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 review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.
Event or Problem Description
It was reported that the pen ndl 32g 4mm was unable to deliver insulin/medication.The following information was provided by the initial reporter: consumer reported ---finding from this box 1 out of every 2-3 pen needles clog during injection verified the lot number and obtained the item # from the box.This user is also a doctor who has medical practice at home address.Reviewed placement of pen needles onto the pen and to complete a flow check with each injection.Consumer resistant to completing this process.Lot #: 8360678, catalog#: 320883, date of event: unknown.

• Brand Name: PEN NDL 32G 4MM
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11575646
• Report Number: 8041187-2021-00216
• Device Sequence Number: 14358053
• 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,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 12/31/2023
• Device Model Number: 320883
• Device Catalogue Number: 320883
• Device Lot Number: 8360678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1