MAUDE Adverse Event Report: BECTON DICKINSON, S.A. ECLIPSE SMARTSLIP; NEEDLES, HYPODERMIC

Catalog Number	305895
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
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.
Event or Problem Description
The incident occurred during the administration of a monthly delayed injection of 5 ampoules of haldol decanoas.During administration, the needle (21g) and syringe (10ml) became disconnected.The 21g needle was reconnected by the nurse by pushing it in and turning it to secure the two parts.The nurse purged the needle and prepared to administer the injection.There was no blood reflux.The nurse slowly pushed the plunger to inject the product.After the injection had begun (at least 1 ml administered), the syringe became detached from the needle, with the needle remaining in the patient's gluteal muscle; the syringe remains in the nurse's hand.The rest of the product therefore comes out of the syringe, making it impossible to know the exact dose of treatment administered.Unfortunately, we do not have any photos or samples of the equipment to show you.Consequences: the patient did not receive the prescribed dose and there is uncertainty about the dose administered.The patient will need to be monitored and reassessed very regularly in order to assess the effectiveness of the treatment.The drug is a slow-release form, so the effects of underdosing may not be immediately apparent.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: as neither a lot number nor a sample was available for this incident, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.However, based on available information, we are not able to identify any possible root cause related to needle manufacturing process at this time.

• Brand Name: ECLIPSE SMARTSLIP
• 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: 23334124
• Report Number: 3002682307-2025-00121
• Device Sequence Number: 18603172
• Product Code: FMI
• UDI-Device Identifier: 00382903058952
• UDI-Public: (01)00382903058952
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 305895
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/19/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown