MAUDE Adverse Event Report: BECTON DICKINSON CANNULA TWINPAK DEVICE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303390
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Device evaluation: it was reported two boxes have the same lot number, but the expiration date is different.To aid in the investigation, one photo was received for evaluation by our quality team.The photo shows two packaging shelf boxes.One shelf box has the expiration date as 2029-05-31 and the second shelf box label has the expiration date as 2024-05-31.This condition occurs if there is a typo when entering the variable data.A device history record review was completed for provided material number 303390, lot 4142679.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported condition.There were no related quality notifications.All processes and final inspections complied with specification requirements.The event will be shared with associates for awareness.Based on the investigation with the photo sample analysis the symptom reported by the customer is confirmed.We appreciate you taking the time to bring this observation to our attention.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.
Event or Problem Description
Material # 303390.Batch # 4142679.It was reported by the customer that the twin pak needles, each have the same lot# but the outdate is very clearly not the same.Verbatim: rcc received a complaint via email.I need to bring this issue to your attention.The product in the picture, (b)(6) twin pak needles, each have the same lot# but the outdate is very clearly not the same.Could you please alert bd and have them provide us some clarification as to the correct date? i have 9 boxes in the storeroom with the earlier outdate, and probably.Item - 303390.Lot - 4142679.
Additional Manufacturer Narrative
(b)(4) follow up: it has been reported that two boxes share the same lot number, yet their expiration dates differ.To assist in the investigation, our quality team received two photographs for evaluation.One photograph depicts two packaging shelf boxes: one with an expiration date of 2029-05-31, and the other with an expiration date of 2024-05-31.The second photograph shows five packaging blister top webs, all bearing the expiration date of 2029-05-31.This discrepancy may have arisen due to a typographical error during the entry of variable data.A device history record review was conducted for material number 303390, lot 4142679.The review did not uncover any quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were identified.All processes and final inspections adhered to specification requirements.This event will be communicated to associates for awareness.Based on the investigation and photo sample analysis, the symptom reported by the customer has been confirmed.

• Brand Name: CANNULA TWINPAK DEVICE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21915937
• Report Number: 1911916-2025-00313
• Device Sequence Number: 12917484
• Product Code: FMI
• UDI-Device Identifier: 00382903033904
• UDI-Public: (01)00382903033904(11)240521(17)290531(10)4142679
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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 Catalogue Number: 303390
• Device Lot Number: 4142679
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/27/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown