MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306553
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd pre-filled saline syringe label information was missing.Report 1 of 2.The following was received by the initial reporter: customer reported prefilled syringe did not have label on it was a blank syringe unable to identify what it was in the pack.No graduation markings either.Another syringe was found with two labels so it appears it was a misprint with the same lot, ref and expiry.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 306553 and lot number 3026599.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.As neither physical samples nor picture samples were available for return, a thorough sample analysis could not be completed.Based on the investigation results, an exact cause could not be determined for this incident.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 PRE-FILLED SALINE SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17757796
• Report Number: 9616657-2023-00038
• Device Sequence Number: 17944639
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: (01)30382903065531
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 01/31/2026
• Device Catalogue Number: 306553
• Device Lot Number: 3026599
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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