MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD FLUSH EXT STERILE; SALINE, VASCULAR ACCESS FLUSH

Model Number	306553
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported there were 3 bd flush ext sterile syringe's missing all print.The following information was provided by the initial reporter: verbatim: it is reported that a number of messages about syringes (306553) missing all print.
Event or Problem Description
It was reported there were 3 bd flush ext sterile syringe's missing all print.The following information was provided by the initial reporter: verbatim: it is reported that a number of messages about syringes (306553) missing all print.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 21-jul-2023.Investigation summary a device history record review was completed for provided material number 306553 and lot number 3026599.The review did not find any detected non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, two (2) picture samples and three (3) physical samples were returned for evaluation by our quality engineer team.Through inspection of the samples, two (2) syringes were found to be missing the barrel label.The third syringe had two (2) barrel labels applied.This incident most likely resulted from a jam in the plunger rod labeler, which was not cleared.After the jam, the defective syringes were not rejected by the vision system at the plunger rod station.An additional control has been initiated, with the installation of a sensor further downstream to inspect 100% of syringes for barrel label presence.

• Brand Name: BD FLUSH EXT STERILE
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17321658
• Report Number: 9616657-2023-00023
• Device Sequence Number: 6894134
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: (01)30382903065531
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: 3026599
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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