MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 30X1/2; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305757
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 30x1/2 needle clogged blocked when i was about to inject besremi, i found that there was resistance when pushing the needle, making it difficult to inject the medication.However, after removing the needle, i could expel air, suggesting a possible needle blockage issue, preventing subcutaneous injection.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the photos, and sample submitted for evaluation.The reported issue of needle clogged/ blocked was not confirmed upon inspection of the sample.Analysis of the sample showed foreign matter causing the clog.It was unable to be extracted from the returned sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this lot meets our manufacturing specification requirements.The assembly process was reviewed, there is a vision system at the assembly machine to detect clogged needles and reject the part.The vision system is challenged at the start of every production shift per inspection form.Current controls include a visual inspection for clogged needles at the quality assurance outgoing inspection and a visual inspection for clogged needles during the assembly in-process inspection.The actual root cause could not be determined as the foreign matter causing the clog could not be extracted.
Event or Problem Description
No additional information.

• Brand Name: BD NEEDLE ECLIPSE 30X1/2
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20847430
• Report Number: 2243072-2024-01196
• Device Sequence Number: 3758248
• Product Code: FMI
• UDI-Device Identifier: 00382903057573
• UDI-Public: (01)00382903057573(11)221207(17)271130(10)2341255
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 305757
• Device Lot Number: 2341255
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown