MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLLUSH

Catalog Number 306575

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Failure to Deliver (2338)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported that the plunger does not move forward to instill the saline.To aid in the investigation, one sample was received for evaluation by our quality team.A visual inspection was performed.The sample came with no packaging flow wrap or saline solution.No defects or imperfections were observed.The sample was then tested for sustaining force and the result was within specification.Based on the investigation results, the sample received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.A device history record review was completed for provided material number 306575, lot number 0352378.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.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.

Event Description

It was reported that the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% plunger was difficult to move during use, and the tip cap was found damaged before opening the packaging.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "correct, this sample was sent because staff reported that was how it was found in the package before opening (white cap was damaged).This was the only syringe found like this.Our concern is the lot #0352378 which the plunger does not move forward to instill the saline.".

• Brand Name: BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLLUSH
• 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: 11713155
• MDR Text Key: 264530557
• Report Number: 1911916-2021-00364
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2021

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: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 306575
• Device Lot Number: 0352378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• 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