MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	320883
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that pen ndl 32g 4mm 90 ct mail order only was clogged during injection.The following information was provided by the initial reporter: material no.320883, batch no.9183109.It was reported that needle clogs during injection.
Event or Problem Description
It was reported that pen ndl 32g 4mm 90 ct mail order only was clogged during injection.The following information was provided by the initial reporter: material no.320883 batch no.9183109.It was reported that needle clogs during injection.
Additional Manufacturer Narrative
H6: investigation summary.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.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

• Brand Name: PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10944194
• Report Number: 9616656-2020-01222
• Device Sequence Number: 4282842
• Product Code: FMI
• UDI-Device Identifier: 00382903208838
• UDI-Public: 00382903208838
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• Number of Events Summarized: 1
• Summary Report (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): 02/10/2021

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: 07/31/2024
• Device Model Number: 320883
• Device Catalogue Number: 320883
• Device Lot Number: 9183109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1