MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD¿ NANO ULTRA-FINE PEN NEEDLE; AUTOINJECTOR NEEDLE

Catalog Number	320883
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: level a investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: a complaint history check was performed and this is the 2nd related complaint for needle clog & the 1st related complaint for needle bent on lot # 8185555.Investigation summary: customer returned (2) 32g 4mm bd pen needles without tear drop labels attached (used).Consumer reported pen needle clog during injection, also noticed that the needle is bent at non patient end, preventing the insulin flow.Both returned samples were examined and the following was observed: 1 returned pen needle was bent at the non-patient end cannula and good on the patient end cannula; no manufacturing defects observed.1 returned pen needle was bent at the non-patient end cannula and slightly bent from use on the patient end cannula; no manufacturing defects observed.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 per the applicable operations and met qc specifications.Based on the above, no additional investigation and no capa is required at this time.Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failures - the bent needles on the non-patient end of the cannulas would be the cause for no medication flowing through, hence the customer would think the needles were clogged (as reported).The slight bending of the patient end cannula would occur after the patient had injected with the pen needle.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: the possible root cause for this issue (bent non-patient end cannula) is: user error.No evidence of manufacturing related issues were observed on the returned samples.It is bd¿s experience that the non-patient end bending is directly associated with the placing of the needle onto the pen device by the user.If the non-patient end of the needle is not placed centrally to the pen device, then instead of the non-patient end of the needle piercing the rubber septum of the vial, it hits hard material and can be bent when fitted to the pen.The possible root cause for this issue (bent patient end cannula) is: human factor.The slight bending of the patient end cannula could have occurred post-injection.No evidence of manufacturing related issues were observed on the returned samples.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that bd¿ nano ultra-fine pen needle clogged during injection.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿material no: 320883, batch no: 8185555.It was reported: that consumer's pen needle clog during injection, also noticed that the needle is bent at non patient end, preventing the insulin flow.Verbatim: consumer reported pen needle clog during injection, also noticed that the needle is bent at non patient end, preventing the insulin flow.Problem occurred (b)(6) 2019, lot # 8185555, product # 320883, exp 06-30-2023.Consumer does not re-use needle, sending mail kit and product voucher.".

• Brand Name: BD¿ NANO ULTRA-FINE PEN NEEDLE
• Common Device Name: AUTOINJECTOR NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8464426
• Report Number: 9616656-2019-00287
• Device Sequence Number: 19312668
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131358
• 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): 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 320883
• Device Lot Number: 8185555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/29/2019
• 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