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

Catalog Number 306547

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: one photo was provided.It shows a syringe connected to a port and it has blood in it.The plunger rod shows a gap with the rubber stopper however it is not fully separated.Failure mode is verified however root cause cannot be determined based on the photo.Please note that the posiflush product is designed to flush the lines, not for drawing blood.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the 2nd complaint for the lot# 9018574 for the same defect or symptom.There was no documentation of issues for the complaint of batch 9018574 during the production run.Root cause description: undetermined.

Event Description

It was reported that an unspecified number of syr 10ml pump compatible saline 10ml fil experienced plunger separation during use.The following information was provided by the initial reporter: material no.: 306547, batch no.: 9018574.Per received email: encountered an issue with one of our flushes.While drawing back blood from a port via a stop-cock, the plunger of the flush became disconnected from the black seal.We realized after grabbing new supplies, that it was just a matter of screwing it back into place.One of the nurses told us this is a known issue for them lately and it sounds like this has happened a few times as well.We did not keep the syringe since it had blood in it.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8557159
• MDR Text Key: 145941932
• Report Number: 1911916-2019-00415
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 306547
• Device Lot Number: 9018574
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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
• Patient Outcome(s): Other