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

Model Number 320550

Device Problems Loose or Intermittent Connection (1371); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

It was reported that bd nano¿ 2nd gen pen needle would not deliver full dose.The following information was provided by the initial reporter: it was reported high blood sugars.Verbatim: parent of consumer reported high blood sugars entire dose of medication is not being delivered.Parent of consumer stated she believes entire dose of medication is not being delivered.Parent of consumer stated she was not experiencing these problems with ultra fine nano pen needles.Parent of consumer stated she tried to purchase ultra fine nano and was told by her pharmacy that the product is no longer available.Advised consumer ultra fine nano is still being manufactured & available for purchase.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.H3 other text : see h10.

Event Description

It was reported that bd nano¿ 2nd gen pen needle would not deliver full dose.The following information was provided by the initial reporter: it was reported high blood sugars.Verbatim: parent of consumer reported high blood sugars entire dose of medication is not being delivered.Parent of consumer stated she believes entire dose of medication is not being delivered.Parent of consumer stated she was not experiencing these problems with ultra fine nano pen needles.Parent of consumer stated she tried to purchase ultra fine nano and was told by her pharmacy that the product is no longer available.Advised consumer ultra fine nano is still being manufactured & available for purchase.

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLE
• Type of Device: PEN 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12800849
• MDR Text Key: 283259486
• Report Number: 9616656-2021-01402
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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: 0309967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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