MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE ECLIPSE 23X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303304
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 303304, batch # unknown.It was reported by customer that they give the injection, the syringe is not fulling emptying.Verbatim: i had one of our physician offices reach out this past week about some issues when giving cortisone shots.They are reporting that when they give the injection, the syringe is not fulling emptying.The needle used is 23gx1.5¿ eclipse sku# 303304 with a 10ml ll syringe sku# 302995.Originally we thought there may have been an issue with the needle-so they noted the lot and removed that lot from use.When another needle was used, there were still issues.They are in the process of removing the lot of syringe and we will be sending new product to them.I¿ll also be working internally with the pharmacy to see if there could have been a change in the medication viscosity.This is a bone & joint practice so this is a frequent procedure, and they are just now having problems so it seems something has changed.Have you heard of any issues with these needles or syringes? i believe our current needle is listed as ¿thin walled¿, is there an alternative needle? i have the lot of needles and will request the syringes should a product complaint need to be filed.Additional information from customer: patient did not receive full dose of medication.No injury.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.No abnormalities were found during visual inspection for clogged needle on the returned samples.The returned samples only contain the eclipse safety needle, syringe is not part of the product.Actual root cause could not be determined as actual sample was not received for investigation.The complaint will be re-opened and re-investigated when actual sample is received.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE ECLIPSE 23X1-1/2 RB TW
• 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20746219
• Report Number: 2243072-2024-01152
• Device Sequence Number: 8297596
• Product Code: FMI
• UDI-Device Identifier: 00382903033041
• UDI-Public: (01)00382903033041(11)230104(17)271231(10)2343744
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• 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): 12/11/2024

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: 303304
• Device Lot Number: 2343744
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown