MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD NEEDLE ECLIPSE S/T; NEEDLES, HYPODERMIC

Catalog Number	305760
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd needle eclipse s/t needle slips off the syringe.The following information was provided by the initial reporter, translated from italian to english: we forward the complaint report for the product 50338767-hypodermic needle w/disp.Safety test 25g 5/8 16 mm eclipse ref.305760 as the needle slips off the connector attachment for the reconstitution of chemotherapy drugs unlike needles without safety even of the same brand.5sep2024 on 3 september there was a dislocation of the needle indicated by a fitting for the reconstitution of chemotherapy drugs (both produced with the luer-lock system).We tested the system on a syringe with saline solution and we realized the incompatibility between the fitting and the needle itself, which did not happen with the previous standard needles (same characteristics) of your brand that do not have the safety system.However, no adverse events have been reported on operators or patients, nor environmental contamination with antiblastic drugs.A further sign that the fitting is from another supplier, but as already explained, your needles without safety are perfectly compatible.¿ have there been any impacts on the patient (serious injuries, medical intervention, need to change treatment)? no ¿ has there been exposure by a healthcare professional to blood or body fluids? no ¿ have any other actions been taken? no ¿ confirm if the samples used are contaminated with blood or cytotoxic drugs.Non-contamination is confirmed.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305760 and lot number 2310003.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, fifty-three (53) unused needle samples were returned.Twenty (20) samples were randomly selected for evaluation by our quality team.The eclipse needles were assembled with a bd discardit 2ml syringe.The snap clips (white part inside of the hub) were properly activated and no signs of defective hub connection were detected.Based on the investigation results, a cause related to the manufacturing process could not be determined for this incident.Smartslip technology ¿ has been introduced to help ensure a secure connection is made with luer slip syringes (the most common syringe design in europe).We recommend that the instructions for use are closely followed as they are unique in recommending the user push firmly when attaching the needle to the syringe and to be sure that the clip is activated.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD NEEDLE ECLIPSE S/T
• Common Device Name: NEEDLES, HYPODERMIC
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20330249
• Report Number: 3002682307-2024-00197
• Device Sequence Number: 7836471
• Product Code: FMI
• UDI-Device Identifier: 50382903057608
• UDI-Public: (01)50382903057608(11)230927(17)280930(10)2310003
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 305760
• Device Lot Number: 2310003
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown