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

Model Number 8975

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: level b investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s2; occurrence: a complaint history check was performed and this is the 1st.Related complaint for difficult/unable to operate & needle bent pe on lot # 9134782.A review of risk management document (b)(4), indicates that the potential risk of this specific reported incident (pen needle, difficult/unable to operate, needle bent pe) was captured and addressed.Investigation summary: no samples (including photos) 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 conformances 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 Description

It was reported that pen ndl 32 g 4 mm 90 ct mail order only was unable to inject during use.The following information was provided by the initial reporter: material no:320883, batch no: 9134782.It was reported that the pen will not depress, it depresses halfway then stops.Also, the needle bent at the patient end before injection.

• Brand Name: PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10611105
• MDR Text Key: 209579833
• Report Number: 9616656-2020-00986
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 9134782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other