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

Catalog Number 306553

Device Problems Volume Accuracy Problem (1675); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported the the bd pre-filled saline syringe scale markings were missing.Report 2 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.

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
• Type of Device: 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: 17757783
• MDR Text Key: 323630974
• Report Number: 9616657-2023-00039
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: (01)30382903065531
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306553
• Device Lot Number: 3026599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1