MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ECLIPSE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305761
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 25x1 rb safety shield broke off (eclipse) it was reported by customer that when attempting to lock the needle after vaccine administration the cap breaks off.Verbatim: rcc received a complaint via email.Email(s) attached.Defective product: eclipse needle for luer-lok syringes, orange hub, 25g x 1¿ manf # 305761.Concern: from (b)(6): when attempting to lock the needle after vaccine administration the cap breaks off.This happened this morning with my back office visit i had.I administered the first vaccine and still had a second one to administer.I made sure parent helped me hold babies' arms so that the baby would not touch the needle that was on my tray.I feel that these needles are very unsafe, and i don't feel safe using them as well.Some of the other caregivers have experienced this issue as well.This is a recent conversion due to a change in the (b)(6).I believe that there was not any education given and this may be a need.Customer response on 25-jul-2025.Bd team, for your information: the concern that you received from me was provided by (b)(6).My part of the process is to be sure that the concerns of the caregiver are passed to the correct place so that we can work together to improve products and patient safety.(b)(6) can you please respond to the below request from bd? thank you all for the attention to this matter.Bd rep response on 25-jul-2025.@productcomplaints ¿ please adjust the contact for this complaint from (b)(6).Additional customer response on 25-jul-2025.Bd team the lot number is 0259457 and yes, i do have a couple of boxes available to return for further investigation.Thank you for your support in resolving this issue.Please feel free to reach out if you have any questions or need further assistance.
Additional Manufacturer Narrative
Our quality engineer inspected the photo and 375 representative samples submitted for evaluation.The reported issue of safety shield broke off was not confirmed upon inspection of the samples.Analysis of the samples showed no damage or defects.No hub hook breakage or safety shield breaks were observed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the defect was not replicated.

• Brand Name: ECLIPSE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22750132
• Report Number: 2243072-2025-00961
• Device Sequence Number: 8716107
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: (01)00382903057610
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• 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): 08/19/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 305761
• Device Lot Number: 0259457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown