MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 18X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305766
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 18x1-1/2 rb has foreign matter material: 305766 batch#: 227661(this lot provided as unknown) and 2336576 it was reported by customer that a qch clinical team, the pharmacy dept, has recently had an issue with bd # needle 18g 1 1/2" 305766 safe.The lots are 227661 exp 2027-09-30 & 2336576 exp 2027-11-30.This is the concern, needles are causing coring in vials for multiple products.Unable to use iv products with particles & coring pieces in the vial.Verbatim: "a qch clinical team, the pharmacy dept, has recently had an issue with bd # needle 18g 1 1/2" 305766 safe.The lots are 227661 exp 2027-09-30 & 2336576 exp 2027-11-30.This is the concern, needles are causing coring in vials for multiple products.Unable to use iv products with particles & coring pieces in the vial.".
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 fm at the qa outgoing inspection per mqa-052/a and visual inspection on fm at the primary packaging in-process inspection per mfg-043/k.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 sample is received.
Event or Problem Description
Material: 305766 batch#: 227661(this lot provided as unknown) and 2336576.It was reported by customer that a qch clinical team, the pharmacy dept, has recently had an issue with bd # needle 18g 1 1/2" 305766 safe.The lots are 227661 exp 2027-09-30 & 2336576 exp 2027-11-30.This is the concern, needles are causing coring in vials for multiple products.Unable to use iv products with particles & coring pieces in the vial.Verbatim: "a qch clinical team, the pharmacy dept, has recently had an issue with bd # needle 18g 1 1/2" 305766 safe.The lots are 227661 exp 2027-09-30 & 2336576 exp 2027-11-30.This is the concern, needles are causing coring in vials for multiple products.Unable to use iv products with particles & coring pieces in the vial.".

• Brand Name: BD NEEDLE ECLIPSE 18X1-1/2 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: 18194098
• Report Number: 2243072-2023-02084
• Device Sequence Number: 7715358
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: (01)30382903057666
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/27/2023

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: Other
• Device Catalogue Number: 305766
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown