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

Catalog Number 306575

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/25/2023

Event Type  malfunction  

Event Description

It was reported that bd posiflush syringe is missing a label.The following information was provided by the initial reporter.No sticker.The syringe is not covered with sticker.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

A device history record review was completed for provided material number 306575 and lot number 3186664.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, retained samples of reported lot number were obtained from the manufacturing facility.The retained samples were evaluated; however, no defects were observed.Per the provided feedback, we understand an issue with barrel label missing.All our prls (plunger rod assembly and labeler) have a vision system to detect issues in the barrel label, including missing label.In this case, the issue could probably be caused after the vision system due to a failure in the double rejection station.If the syringe has no label, the rejection station must reject it.However, if there is a failure in the rejection, the station stops and it does not allow to run the machine.Then, the operator must check which is the cause of the stoppage and remove the defective samples.This is a very unusual circumstance.Labelling is inspected on regular basis under quality assurance control sampling procedure.Based on our stringent sampling inspection, we are certain that the probability of occurrence of this non-conformance is low and this should correspond to an isolated case.However, an awareness bulletin for the reported defect has been communicated to the manufacturing affected area and a training has been conducted.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.H3 other text : see narrative below.

• Brand Name: BD POSIFLUSH SYRINGE
• 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, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18544726
• MDR Text Key: 333522010
• Report Number: 3002682307-2024-00005
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065752
• UDI-Public: (01)00382903065752
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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: Lay User/Patient
• Device Catalogue Number: 306575
• Device Lot Number: 3186664
• 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: 04/03/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1