MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 22X1-1/2 RB; SYRINGE

Catalog Number	305763
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 22x1-1/2 rb needle was clogged / blocked it was reported by customer that the pressure that needs to be used is too excessive and will cause injury to the dr.Verbatim: rcc received a complaint via email.Email(s) attached.Please follow up with xxx at xxx (ext: (b)(6) for the product concern outlined below within 3 business days; and advise of any special shipping instructions for pick up, courier or discarding of product.Please investigate and follow up with a written report from your quality assurance as to your findings and resolutions.Product concern ticket number: (b)(4).Date of incident: 22-apr-2024 hospital: (b)(6).Department: breast health clinic.Product: needle safe 22g x 1.5 305763 vmid: (b)(4).Lot number: 1118936 product expiry date: 30-apr-2026 number of defective product(s): 1 is sample available: yes concern description: 23g needle is not suitable for breast aspirations.The pressure that needs to be used is too excessive and will cause injury to the dr.21g is too small for the aspirate.Thank you in advance for your follow-up on this product concern.
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
Material # 305763, lot # 1118936.It was reported by customer that the pressure that needs to be used is too excessive and will cause injury to the dr.Verbatim: rcc received a complaint via email.Please follow up with xxx at xxx (ext: (b)(6) for the product concern outlined below within 3 business days; and advise of any special shipping instructions for pick up, courier or discarding of product.Please investigate and follow up with a written report from your quality assurance as to your findings and resolutions.Product concern ticket number: (b)(4).Date of incident: (b)(6) 2024.Hospital: (b)(6).Product: needle safe 22g x 1.5 305763.Vmid: (b)(4).Lot number: 1118936.Product expiry date: 30-apr-2026.Number of defective product(s): 1.Is sample available: yes.Concern description: 23g needle is not suitable for breast aspirations.The pressure that needs to be used is too excessive and will cause injury to the dr.21g is too small for the aspirate.Thank you in advance for your follow-up on this product concern.

• Brand Name: BD NEEDLE ECLIPSE 22X1-1/2 RB
• Common Device Name: SYRINGE
• 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: 19584358
• Report Number: 2243072-2024-00738
• Device Sequence Number: 15252821
• Product Code: FMI
• UDI-Device Identifier: 00382903057634
• UDI-Public: (01)00382903057634
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/25/2024

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: 04/30/2026
• Device Catalogue Number: 305763
• Device Lot Number: 1118936
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown