MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Defective Component (2292)

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

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.6 investigation summary: it was reported the syringes caused the alaris syringe module to alarm.To aid in the investigation, two empty syringes no with no tip cap or packaging flow wrap were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then tested for sustaining force per it287, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the results were within specification.A device history record review was completed for provided material number 306547, lot 3059592.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 2 of the bd posiflush¿ normal saline syringe, in 10 ml alarms during use of syringes.The following information was provided by the initial reporter: it was reported by the clinician occasionally there are issues with downstream pressure alarms with their posi flush 10 ml pre-filled saline flush syringes (product number 306547).The clinician provided two posi flush used on the alaris syringe module which 1) caused excessive alarms while infusing during (almost halfway during the flush and 2) the pre-filled syringe "that did not work and alarmed" and both syringes were removed and replaced.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17143609
• MDR Text Key: 317945528
• Report Number: 1911916-2023-00408
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2023

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
• Device Operator: Other
• Device Catalogue Number: 306547
• Device Lot Number: 3059592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1