MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 5ML SALINE FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306594

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.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: 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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: no root cause can be determined as no samples were received.Rationale: capa not required at this time.

Event Description

It was reported that the plunger is defective with a bd syringe 5ml saline fill.This was discovered before use.The following information was provided by the initial reporter: at 11:00 am, on (b)(6) 2020, the cardiology nurse prepared to use a prefilled catheter irrigator to plug the indwent needle mouth, and opened a prefilled catheter irrigator.She found a piece of defect in the needle plug, which was suspected to be due to the quality problem of the batch number of prefilled catheter irrigators.The hospital equipment department was immediately informed and a new prefilled catheter irrigator was used by the patient.

• Brand Name: BD SYRINGE 5ML SALINE FILL
• 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: 10229585
• MDR Text Key: 199140225
• Report Number: 1911916-2020-00597
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8298506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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