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	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Medical device lot #: the customer provided lot # 8144593.This does not match the catalog number provided.Device manufacture date: unknown.(b)(4).Investigation summary: level a 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 does not attach/detach on lot # 8144593.A review of risk management document (b)(4) revision 18, indicates that the potential risk of this specific reported incident (pen needle: does not attach/detach) was captured and addressed appropriately.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 needle 32g 4mm 5b xtw 7ct carton was difficult to remove from the insulin pen.This was discovered during use.The following information was provided by the initial reporter: material no: 320540 batch no: 8144593.It was reported that the pen needle was difficult to remove from insulin pen.

• 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: 10156093
• Report Number: 9616656-2020-00547
• Device Sequence Number: 14293005
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 320540
• Device Catalogue Number: 320540
• Device Lot Number: 8144593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/15/2020
• 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