MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE; NEEDLES, HYPODERMIC

Catalog Number	302437
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd eclipse needle becomes clogged.The following information was provided by the initial reporter, translated from spanish to english: in the absence of more reports, the main thing they tell me is that they get blocked as soon as you prick the iv to load, that is to say, you prick the iv and they neither extract it nor can you put the medication in the iv (they are not permeable), and this happens at least 75% of the time (this is no exaggeration) and you need to use 3 needles to load a zofran and a dexa, for example, every day, many times.We are still waiting for other complaints from different services.Additional information received on 13-feb-2025 when using the needles to carry medication, the needle gets stuck, preventing the passage of fluid and having to use several needles for the same process, or in the worst case having to use another needle that is intended for another purpose because the needles for loading medication are not practical and make the task difficult.The event occurs daily.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 302437 and batch number 2409009.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty (20) retained samples of reported lot number were obtained from the manufacturing facility.The needles were assembled with a bd discardit 2ml syringe; however, no signs of defective connection were observed; also liquid went through the cannula normally, no clogged needle issue was found.Based on the investigation results, we were unable to reproduce the reported issue and an exact cause could not be determined.Regarding the feedback of clogged needle, we understand coring effect issue had taken place.Based on the preventive measures in place, it is unlikely that the coring effect resulted from poor or insufficient de-burring of the cannula.It is possible that the handling of the product had a role in this incident.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD ECLIPSE
• Common Device Name: NEEDLES, HYPODERMIC
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21460845
• Report Number: 3002682307-2025-00027
• Device Sequence Number: 20743574
• Product Code: FMI
• UDI-Device Identifier: 00382903024377
• UDI-Public: (01)00382903024377(11)240904(17)290831(10)2409009
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 302437
• Device Lot Number: 2409009
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown