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

Catalog Number	305757
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a140901 - complete blockage.
Event or Problem Description
Materials#: 305757 batch#: 2341255.It was reported by the customer that instant blockage when trying to administer medicine through needle.Verbatim: instant blockage when trying to administer medicine through needle.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a visual inspection on clogged needle at the qa outgoing inspection per mqa-052/a and visual inspection on clogged needle at the assembly in-process inspection per mfg-043/i.Actual root cause could not be determined as no sample were received for investigation.The complaint will be re-opened and re-investigated when sample is received.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Materials#: (b)(4) batch#: 2341255 it was reported by the customer that instant blockage when trying to administer medicine through needle.Verbatim: instant blockage when trying to administer medicine through needle.

• Brand Name: NEEDLE ECLIPSE 30X1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18236968
• Report Number: 2243072-2023-02116
• Device Sequence Number: 16950197
• Product Code: FMI
• UDI-Device Identifier: 30382903057574
• UDI-Public: (01)30382903057574
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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 Catalogue Number: 305757
• Device Lot Number: 2341255
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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