MAUDE Adverse Event Report: BECTON DICKINSON PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY; PEN NEEDLE

Model Number	8975
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: (b)(4).Medical device lot #: the customer provided lot # 8015571.This does not match the catalog number provided.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown, medical device lot #: 5006486, medical device expiration date: na, device manufacture date: 2015-02-11.The customer's address is unknown.(b)(6) usa has been used as a default.(b)(4).Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st.Related complaint for incorrect/missing label information & expired product on lot # 5006486.A review of risk management document (b)(4) indicates that the potential risk of this specific reported incident (pen needle, incorrect/missing label information, expired product) was captured and addressed.Investigation summary: no samples were returned therefore the complaint could not be confirmed.If samples are received in the future the complaint will be reopened for further investigation.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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 investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that pen ndl 31g 5mm 90 count mail order only had no expiration date.This was discovered during use.The following information was provided by the initial reporter: material no.320882 batch no.5006486, unknown (provided: 8015571).It was reported that there is no expiration date on shelf cartons.Verbatim: consumer called to inquire about pen needle expiration date.Stated there is no expiration date on the product box.Consumer also could not locate a copyright date.Consumer stated she did use some of these pen needles.Informed that these could be expired and that bd tests the products for 5 years.

• Brand Name: PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10646461
• Report Number: 2243072-2020-01601
• Device Sequence Number: 3124188
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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: 8975
• Device Catalogue Number: 320882
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/07/2020
• 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