MAUDE Adverse Event Report: BECTON DICKINSON CANNULA BLUNT PLASTIC; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303345
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material number: 303345.Batch number: unknown.We have had 15-20 reports of coring, stoppers being pushed into vials, and even parts of stoppers breaking off.Our list of meds involved is super varied and the manufacturers are different too - pfizer, hospira, american regent, amneal, and fresenius kabi.We have 3-4 different kinds of blunt tip needles as well - bd blunt fill needle ref 305180, blunt fill needle, covidien 8881850310, blunt fill needle, covidien, 8881540111, bd cannula blunt sterile latex free plastic ref 303345.Has anyone contacted manufacturers regarding material used in stoppers? i spoke with an amneal rep and they could not say that anything has changed with the manufacturing process or materials used.
Additional Manufacturer Narrative
(b)(4) follow up as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
No additional information received.

• Brand Name: CANNULA BLUNT PLASTIC
• 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: 21303429
• Report Number: 1911916-2025-00076
• Device Sequence Number: 15683961
• Product Code: FMI
• UDI-Device Identifier: 00382903033454
• UDI-Public: (01)00382903033454(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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): 02/07/2025

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: 303345
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown