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 01/10/2024

Event Type  malfunction  

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

It was reported that bd posiflush syringe is missing markings.The following information was provided by the initial reporter, translated from chinese to english: the syringe without stick and mark.

Event Description

07-feb-2024: it means there is no printing scale or labeling sticker on the barrel.

Manufacturer Narrative

A device history record review was completed for provided material number 306575 and lot number 3130723.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.Although a shipment was noted as being generated, unfortunately, no sample has been received at the investigative plant for evaluation.If a sample is received, further analysis will be performed.The labeling process has a vision system in place to detect any issues with a missing label.In this case, a failure may have occurred in the double rejection station.If the syringe has no label the rejection system must reject it.If there is a failure in this rejection, the station stops and the operator must resolve the issue to move forward.It is also possible that the sensor was slightly moved which caused the defective syringe to go undetected.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 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: 18619308
• MDR Text Key: 334724346
• Report Number: 3002682307-2024-00014
• 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: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2024

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: 3130723
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 07/16/2024
• Supplement Dates FDA Received: 07/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1