MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ECLIPSE¿; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364389
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) investigation summary: "material #: 364389 lot/batch #: 3151632 bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for missing iv shield was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of missing iv shield was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode missing iv shield.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".
Event or Problem Description
It was reported prior to using a bd preset¿ eclipse¿ syringe, the syringe was missing its iv shield resulting in a clean needle stick injury to the user.An additional syringe was found without an iv shield in the same shelf carton.No further impact was reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 14-aug-2024.Investigation summary material #: 364389.Lot/batch #: 3151632.Bd received 2 samples and 3 photos for investigation.The samples and photos were evaluated and the indicated failure mode for missing iv shield was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of missing iv shield was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode missing iv shield.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported prior to using a bd preset¿ eclipse¿ syringe, the syringe was missing its iv shield resulting in a clean needle stick injury to the user.An additional syringe was found without an iv shield in the same shelf carton.No further impact was reported.

• Brand Name: BD PRESET¿ ECLIPSE¿
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19973176
• Report Number: 9617032-2024-01198
• Device Sequence Number: 7115401
• Product Code: JKA
• UDI-Device Identifier: 50382903643894
• UDI-Public: (01)50382903643894
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K202446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: Other
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 364389
• Device Lot Number: 3151632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown