MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Model Number 306546

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was performed for provided lot number 223825.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, four samples were received for evaluation by our quality team.The samples came with no saline solution and with the plunger rod- rubber stopper all the way down.A visual inspection was performed and no defects or imperfections were observed.Then, each sample was tested for sustaining force and the results were within specification.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer could not be confirmed.Root cause description: the cause for this defect could have resulted if the customer noticed that more than usual force was required to expel the solution, as one of the samples force result was towards the high specification limit.Rationale: further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

Event Description

It was reported that the bd posiflush¿ normal saline syringe plunger was difficult to push after "5 ml" had been injected.The following information was provided by the initial reporter: "10 ml 0.9% saline syringes become very difficult to push after 5 ml has been injected.Initially, we thought it was an iv issue, but we have had several syringes from the same lot that we've had an issue with.It has been reported this has happened on multiple occasions and it has happened with flushes from different boxes.The first few times it was thought to be an iv issue.Iv tubing information: they use bd saf-t-intimas but we have had this issue with patients that have angiocaths as well".

• Brand Name: BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11286428
• MDR Text Key: 230577633
• Report Number: 1911916-2021-00096
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 0223825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2020
• 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