MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE VASCULAR ACCESS FLUSH

Model Number 306547

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: a device history record review was completed for provided material number 306547 and lot number 0281382.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation one sample was received for evaluation by our quality team.The sample came with 3ml of blood and no tip cap.The plastic bag has a written note, "do not open." for safety and contamination reasons, no additional evaluation or testing was performed.The sample was discarded to protect associates.Based on the investigation results, the sample received could not be tested and an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Capa not required at this time.

Event Description

It was reported that the syr 10ml pump compatible saline 10ml fil had difficult plunger movement that stopped flushing saline halfway through.The following information was provided by the initial reporter: "nurses have had issues with port needles that stopped flushing in the middle of accessing a patient's port.They believe the issue may be with the saline flush.The port nurse had stuck the patient, flushed with half of the saline and then it quit, she was able to draw back a little bit, but then it quit again.The nurse switched the saline flush and didn't have any problems with flushing after that.When she took a look at the flush that had the issue, she looked to see if maybe there was clot or something blocking the opening of the flush, but she didn't see anything.".

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• 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: 11386704
• MDR Text Key: 234008017
• Report Number: 1911916-2021-00169
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• 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: 02/19/2021

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: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: 0281382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2020
• 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