MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NEEDLE 32G 4MM 5B XTW 7CT CARTON; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	320540
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7052840, medical device expiration date: na, device manufacture date: 2018-04-11, medical device lot #: 7012659, medical device expiration date: 2022-01-31, device manufacture date: 2017-09-13.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.Investigation summary: occurrence: a complaint history check was performed and this is the 1st.Related complaint for incorrect/missing label information on lot # 7052840 & lot # 7012659.No samples 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 conformance's were raised in association with these packaged lots concluding all inspections were performed as per the applicable operations and met qc specifications.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that there was no expiration date on 5 packs of pen needles 32g 4mm 5b xtw 7ct carton in lot# 7052840, and an unspecified number of packs from lot# 7012659, before use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "spouse of consumer called to confirm if sample packs of bd pen needles are still good.Stated there is no expiration date on any of the packs, however confirmed a copyright date of 2016 on all sample packs.".

• Brand Name: PEN NEEDLE 32G 4MM 5B XTW 7CT CARTON
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10053585
• Report Number: 9616656-2020-00422
• Device Sequence Number: 19771093
• Product Code: FMI
• UDI-Device Identifier: 00382903205400
• UDI-Public: 00382903205400
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

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: 320540
• Device Catalogue Number: 320540
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other