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	09/18/2024
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.B3.The date received by manufacturer has been used for this field.Batch #4060580, 4023389, 2336576, 3360148, 4084129.
Event or Problem Description
It was reported that bd needle eclipse 18x1-1/2 rb coring needle it was reported by customer that have had "coring" in multiple iv admixtures and drug reconstitution.We initially thought this could have been the stopper the manufacturer is using; however, the broadness of the different product affected and the staff mentioning that the sharpness of the needles not being up to standard (they are duller) and not perforating the rubber part adequately resulting in particulates of rubbers in the solutions requiring extra filtration process (very time consuming and possible for some other products to maintain drug formulation integrity) or even wastage of entire batches.Verbatim: rcc received a complaint via email.Email(s) attached.We have had "coring" in multiple iv admixtures and drug reconstitution.We initially thought this could have been the stopper the manufacturer is using; however, the broadness of the different product affected and the staff mentioning that the sharpness of the needles not being up to standard (they are duller) and not perforating the rubber part adequately resulting in particulates of rubbers in the solutions requiring extra filtration process (very time consuming and possible for some other products to maintain drug formulation integrity) or even wastage of entire batches.
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 needle point blunt 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# 305766; batch #4060580/ 4023389/ 2336576 / 4084129 / 3360148.It was reported by customer that have had "coring" in multiple iv admixtures and drug reconstitution.We initially thought this could have been the stopper the manufacturer is using; however, the broadness of the different product affected and the staff mentioning that the sharpness of the needles not being up to standard (they are duller) and not perforating the rubber part adequately resulting in particulates of rubbers in the solutions requiring extra filtration process (very time consuming and possible for some other products to maintain drug formulation integrity) or even wastage of entire batches.Verbatim: rcc received a complaint via email.Email(s) attached.We have had "coring" in multiple iv admixtures and drug reconstitution.We initially thought this could have been the stopper the manufacturer is using; however, the broadness of the different product affected and the staff mentioning that the sharpness of the needles not being up to standard (they are duller) and not perforating the rubber part adequately resulting in particulates of rubbers in the solutions requiring extra filtration process (very time consuming and possible for some other products to maintain drug formulation integrity) or even wastage of entire batches.

• 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: 20455297
• Report Number: 2243072-2024-01041
• Device Sequence Number: 15761061
• Product Code: FMI
• UDI-Device Identifier: 00382903057665
• UDI-Public: (01)00382903057665(11)240403(17)290331(10)4084129
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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 Catalogue Number: 305766
• Device Lot Number: 4084129
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown