MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 23G ETW X 7MM PEN NEEDLE US

Model Number	4736989
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 23g etw x 7mm pen needle us needle was short.The following information was provided by the initial reporter: bdp: low fill volume-pen diluent & others (short needle).
Event or Problem Description
It was reported that 23g etw x 7mm pen needle us needle was short.The following information was provided by the initial reporter: bdp: low fill volume-pen diluent & others(short needle).
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-21.H6: investigation summary: customer returned (1) open 7mm, 23g pen needle without any packaging.Customer states that the needle is short.The returned pen needle was tested for patient end cannula length (specs for 7mm cannula length: 0.229¿-0.323¿).The patient end of the cannula was measured as 0.275¿, which falls within specifications.A review of the device history record was completed for batch# 8275681.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: 23G ETW X 7MM PEN NEEDLE US
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11115039
• Report Number: 1920898-2020-01792
• Device Sequence Number: 17045966
• Product Code: FMI
• UDI-Device Identifier: 00382904736989
• UDI-Public: 00382904736989
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K110105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Model Number: 4736989
• Device Catalogue Number: 47369802
• Device Lot Number: 8275681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1