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

Catalog Number 306575

Device Problem Missing Information (4053)

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

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.

Event Description

It was reported that bd posiflush pre-filled syringe has no markings on the syringe.The following information was provided by the initial reporter, translated from chinese to english: the printing of the product is lost.

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.To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, a syringe was observed without the barrel label.Although the production history records did not show any issues, this defect most likely resulted from a failure in the vision system.The machinery has a vision system in place to detect issues with the barrel label, including missing label.If a syringe has no label, the rejection station must reject it; however, if there is a failure in this rejection, the station stops and the operator must identify the cause of stoppage and resolve the issue.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.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 POSIFLUSH PRE-FILLED 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: 18520348
• MDR Text Key: 333506773
• Report Number: 3002682307-2024-00001
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: Other
• Device Catalogue Number: 306575
• Device Lot Number: 3186664
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1