MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH SYRINGE XS; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that bd posiflush syringe xs syringe barrel is not labeled.The following information was provided by the initial reporter: one of my senior staff who works in vascular access found this syringe inside on of our pivc insertion packs.It is labelled outside as a sterile posiflush though there is no labelling on the actual syringe for identification.In this instance this item was not flushed into the patient.

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 Description

No additional information.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 2052102.The review did not reveal any detected non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, three (3) pictures and one (1) physical sample were returned for evaluation by our quality team.Through examination of the sample, a missing barrel label was identified.The missing barrel label most likely resulted from a jam in the labeler machinery which was not appropriately cleared.In turn, the defective syringe was not rejected by the vision system in place.A control report has been initiated which will see to the installation of a sensor further downstream in the manufacturing line for 100% inspection of barrel label presence.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD POSIFLUSH SYRINGE XS
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18547334
• MDR Text Key: 333332156
• Report Number: 3002682307-2024-00006
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 306572
• Device Lot Number: 2052102
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1