MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE; NEEDLE, HYPODERMIC

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	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.
Event or Problem Description
It was reported that bd needle eclipse cored the vial rubber.The following information was provided by the initial reporter: when you insert [eclipse needle] into any vial with a rubber top, it is noted to have a little piece of the rubber top left in the syringe.¿ is this something you have heard other sites having issues with.
Additional Manufacturer Narrative
The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.
Event or Problem Description
Material#: 305766.Lot#: unknown.It was reported by the customer reported that when you insert [eclipse needle] into any vial with a rubber top, it is noted to have a little piece of the rubber top left in the syringe.¿ is this something you have heard other sites having issues with.Verbatim: when you insert [eclipse needle] into any vial with a rubber top, it is noted to have a little piece of the rubber top left in the syringe.¿ is this something you have heard other sites having issues with.

• Brand Name: BD NEEDLE ECLIPSE
• Common Device Name: NEEDLE, HYPODERMIC
• 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: 18670943
• Report Number: 2243072-2024-00146
• Device Sequence Number: 20848950
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: (01)30382903057666
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: Other
• Device Catalogue Number: 305766
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown