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

Catalog Number	305891
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/05/2025
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
It was reported that bd needle eclipse s/t safety mechanism did not engage.The following information was provided by the initial reporter, translated from french to english: on (b)(6) 2025, while taking a blood gas sample, the nurse was unable to engage the safety device on the hypodermic canula.She described resistance when lowering the safety device.The nurse then tried to lower the safety catch with her second hand.The safety catch then disengaged from the canula.The canula penetrated the glove and pricked the nurse, resulting in a blood exposure accident.The defective device was not kept by the nurse.The nurse was consulted in the hospital's emergency department following the blood exposure accident.Medical follow-up has been organized.At present, no post-exposure prophylaxis has been initiated, given the negative virological status of the patient sampled.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305891 and lot number 2407007.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.As samples were unavailable for return, twenty (20) retained samples of the reported lot number were obtained from the manufacturing facility for evaluation by our quality team.Through examination of the samples, no defects were identified with the safety mechanisms and it was possible to activate them following the instructions for use.Based on the investigation results, an exact cause could not be determined for this incident.If the affected sample becomes available for this incident or any potential future occurrences, we would greatly appreciate the opportunity to conduct a thorough analysis.Every lot is tested for safety shield activation before release.The assembly process has a system that inspects all product for proper opening and activation of the safety shield, rejecting any defects identified.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 ECLIPSE
• 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: 21709688
• Report Number: 1710034-2025-00486
• Device Sequence Number: 10010714
• Product Code: FMI
• UDI-Device Identifier: 50382903058919
• UDI-Public: (01)50382903058919(11)240627(17)290630(10)2407007
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 305891
• Device Lot Number: 2407007
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown