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

Catalog Number	305886
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
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.E1.Address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
It was reported that bd eclipse smartslip medication leakage between needle hub and syringe slip.The following information was provided by the initial reporter: date of incident (yyyy-mm-dd): 2024-07-21.Level of harm: minimal harm.Incident details: when giving rhogam, the needle did not align well with the syringe, most of the rhogam was not administered to the patient as it leaked out at the top of the syringe.Impact of incident: ineffective dose.
Additional Manufacturer Narrative
Additional information received found in b describe event or problem.Annex e and f codes updated.
Event or Problem Description
Additional information received on 27aug.1.It was initially stated that minimal harm occurred.Please define the harm.Patient required a second poke/dose.2.Did the patient receive a full dose of the medication by alternate injection? if no, please describe.Yes.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305886 and lot number 2101010.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.All engagement force results were found to be within specifications for this lot number.As samples were unavailable for return, twenty retained samples of the same lot number were obtained for further evaluation by our quality engineer team.The retained samples were assembled with a bd discard it 2ml syringe.No signs of defective hub connection were identified nor were any signs of leakage detected.Based on the investigation results, an exact cause related to the needle manufacturing process could not be determined at this time.Smartslip technology ¿ has been introduced to ensure a secure connection is made with luer slip syringes.We recommend that the instructions for use are closely followed for the bd eclipse smartslip, which are unique in recommending that the user push firmly when attaching the needle to the syringe and to be sure that the clip component is activated.Also, our needles are manufactured and released according to applicable procedures and specifications that complies with iso (international organization for standardization) standards.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.

• Brand Name: BD 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: 20010997
• Report Number: 3002682307-2024-00163
• Device Sequence Number: 14590508
• Product Code: FMI
• UDI-Device Identifier: 50382903058865
• UDI-Public: (01)50382903058865
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

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: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 305886
• Device Lot Number: 2101010
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: Not provided; 09/20/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 08/29/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown