MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 2865

Device Problems Misconnection (1399); Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: level b 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 3rd related complaint for needle clog on lot # 8247891.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.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 per the applicable operations and met qc specifications.Investigation conclusion: based on the samples / photo(s) 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 has been reported that one bd ultra-fine¿ nano¿ pen needles 4mm (5/32¿) 32g has been found experiencing difficulty to operate during use.The following has been provided by the initial reporter: it was reported that the needle was blocked.Verbatim: needle blocked.

Manufacturer Narrative

Correction: sample received.New investigation completed.The following information has been updated: h.6.Investigation summary: level b 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 3rd related complaint for needle clog on lot # 8247891.Investigation summary: customer returned one (1) used 32g x 4mm bd pen needle without a cover, tear drop label, or inner shield attached.Consumer reported needle blocked.The returned pen needle was examined, then tested for flow using a test pen injector: the returned pen needle was not able to expel properly.A wire test was then performed on this sample: the wire passed through the cannula, however, there was a small, clear residue observed at the tip of the wire after being through the cannula.Under the microscope the residue was identified as residual silicone from the manufacturing process.Investigation by the manufacturer (dun laoghaire) is not necessary as the silicone residue was already identified and removed from the sample.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.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 failure (clog) 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: some residual silicone from the manufacturing lubrication process could be the cause for slight blockage of the flow.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It has been reported that one bd ultra-fine¿ nano¿ pen needles 4mm (5/32¿) 32g has been found experiencing difficulty to operate during use.The following has been provided by the initial reporter: it was reported that the needle was blocked verbatim: ¿ needle blocked.

• Brand Name: BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9521641
• MDR Text Key: 193660955
• Report Number: 9616656-2019-01270
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: 10885403928659
• Combination Product (y/n): N
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 2865
• Device Catalogue Number: 320122
• Device Lot Number: 8247891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other