MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 320550

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

Patient Problem Hyperglycemia (1905)

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd nano¿ 2nd gen pen needle would not deliver insulin during the injection nor the flow check, and the button was difficult to press when attempting the injection.Additionally, the consumer's blood glucose level rose to 379.The following information was provided by the initial reporter: "consumer reported found 1 pen needles when i placed onto the pen, insulin would not appear.Tried to inject with it, but dose button would not go down easy.Removed from site completed a flow check this did not work.Glucose levels went up to 379.Took a pen needle from another box to take more insulin than normal.Caller also wears dexcom monitor.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 12-sep-2022.H6: investigation summary: customer returned (1) open 32gx4mm bd pen needle without a tear drop label attached.The customer reported that insulin would not appear, the dose button would not go down easy, and glucose levels went up.The sample was examined, and it was observed that the non-patient end (npe) cannula was broken.No evidence of manufacturing defect was observed.The broken npe cannula would prevent proper flow through the pen needle, hence, the customer would think the pen needle was clogged ¿ this would have prevented the pen dose button from depressing properly, thus, not allowing medication to be delivered.Since the sample was returned after use, the probable cause of the broken npe cannula is user error when attaching the pen needle to a pen injector.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.Embecta was able to duplicate or confirm the customer¿s indicated failure.The root cause for this issue is user related.The npe cannula was broken after the customer handled the pen needle.

Event Description

It was reported that the bd nano¿ 2nd gen pen needle would not deliver insulin during the injection nor the flow check, and the button was difficult to press when attempting the injection.Additionally, the consumer's blood glucose level rose to 379.The following information was provided by the initial reporter: "consumer reported found 1 pen needles when i placed onto the pen, insulin would not appear.Tried to inject with it, but dose button would not go down easy.Removed from site completed a flow check this did not work.Glucose levels went up to 379.Took a pen needle from another box to take more insulin than normal.Caller also wears dexcom monitor.".

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15460494
• MDR Text Key: 306099159
• Report Number: 9616656-2022-01016
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: (01)00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 1145129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/21/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• 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