MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305767
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd needle eclipse 25x1-1/2 rb leaked.It was reported by customer that during the ip administration there was some leakage from the needle, and they are unsure whether all the ip has been administered to the subject.Per site: "we checked the connections etc as this is standard practice.We struggle to see where the leakage was coming from due to the size of the needle.I would never insert the needle completely in as for safety purposes you need to ensure that there is enough to get hold of should it break away from the hub.2/3 of the way is normal standard practice.We both checked the connection which is again standard practice.It's also a batch we have used before but that doesn't rule out a problem.Rcc received a complaint via email.1 ml syringe 309628: lot#: 1082594.25g needle 305767: lot#: 1028656.Site mentions that during the ip administration there was some leakage from the needle, and they are unsure whether all the ip has been administered to the subject.Per site: "we checked the connections etc as this is standard practice.We struggle to see where the leakage was coming from due to the size of the needle.I would never insert the needle completely in as for safety purposes you need to ensure that there is enough to get hold of should it break away from the hub.2/3 of the way is normal standard practice.We both checked the connection which is again standard practice.It's also a batch we have used before but that doesn't rule out a problem." the site/sponsor is unsure if the leak came from the needle or the syringe.The needle was not retained for safety reasons.No photos are available of the impacted needle/syringe.
Additional Manufacturer Narrative
F code updated.

• Brand Name: BD NEEDLE ECLIPSE 25X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20362062
• Report Number: 2243072-2024-01008
• Device Sequence Number: 9592379
• Product Code: FMI
• UDI-Device Identifier: 00382903057672
• UDI-Public: (01)00382903057672(11)210128(17)260131(10)1028656
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: NL
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: 01/31/2026
• Device Catalogue Number: 305767
• Device Lot Number: 1028656
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown