MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 23G ETW X 7MM PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	4736989
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 1 bd 23g etw x 7mm pen needle was difficult to operate.The following information was provided by the initial reporter: the needle could not be injected properly even though it was injected by the hospital staff.
Event or Problem Description
It was reported that 1 bd 23g etw x 7mm pen needle was difficult to operate.The following information was provided by the initial reporter : the needle could not be injected properly even though it was injected by the hospital staff.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.
Event or Problem Description
It was reported that 1 bd 23g etw x 7mm pen needle was difficult to operate.The following information was provided by the initial reporter: the needle could not be injected properly even though it was injected by the hospital staff.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/19/2021.H.6.Investigation: customer returned (1) open 7mm, 23g pen needle without the tear drop label.Customer states that the needle could not be injected properly.The returned pen needle was tested for point geometry, lube, and cannula od (specs: outer diameter for 23g: 0.0260¿-0.0265¿).The point exhibited proper geometry, the outer diameter was measured as 0.0263¿, and sufficient lube was observed.Also, no blocked/clogged cannula was observed on the sample.All observations fell 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.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: 23G ETW X 7MM PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12393477
• Report Number: 1920898-2021-00945
• Device Sequence Number: 11933909
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2021

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: Health Professional
• 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: 10/19/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 10/01/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/28/2021; 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1