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

Catalog Number	305767
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
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 25x1-1/2 rb needle was clogged / blocked.It was reported by the customer that the 25-gauge 1 inch needle did not have a hole in it.Verbatim: rcc received a complaint via email.Email(s) attached.The 2nd needle was discovered on 5/23/24 and the safety zone portal incident f77576 was created: lot info: bd eclipse needle, 25g 1 ½ inch, exp date 2025-09-30, lot 0275242.We have the original packaging but not the needle.We are also quarantining any remaining needles we have from this lot.
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 and visual inspection on clogged needle at the assembly in-process inspection.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.
Event or Problem Description
Materials#: 305767, batch#: 0275242.It was reported by the customer that the 25-gauge 1 inch needle did not have a hole in it.Verbatim: rcc received a complaint via email.The 2nd needle was discovered on 5/23/24 and the safety zone portal incident f77576 was created: lot info: bd eclipse needle.25g 1 ½ inch.Exp date 2025-09-30.Lot 0275242.We have the original packaging but not the needle.We are also quarantining any remaining needles we have from this lot.

• 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 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: 19567186
• Report Number: 2243072-2024-00731
• Device Sequence Number: 12297171
• Product Code: FMI
• UDI-Device Identifier: 00382903057672
• UDI-Public: (01)00382903057672
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/10/2024

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: 09/30/2025
• Device Catalogue Number: 305767
• Device Lot Number: 0275242
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown