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

Catalog Number 306546

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 04/26/2023

Event Type  Injury  

Event Description

It was reported that the patient reported an infection while using bd posiflush iv flush normal saline filled syringe.This is the 3rd of 3 patients.The following information was provided by the initial reporter: product concern: per customer-i was notified that 3 patients from last week reported an infection in the iv insertion site area.We excluded several factors and left a few by identifying the common denominator, saline being one of the common denominators.This morning an iv was placed and as soon as the normal saline was injected, pt expressed pain and had a hard bump, and the area started swelling up.Making me believe it was the saline.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Lot number was not reported; however, a potential lot number was provided.The information for that number is as follows: d4.Medical device lot #: 2340250; d4.Medical device expiration date: 30-nov-2025; h4.Device manufacture date: 06-dec-2022.D4.Medical device lot #: 3031739; d4.Medical device expiration date: 31-jan-2026; h4.Device manufacture date: 31-jan-2023.D4.Medical device lot #: 2297879; d4.Medical device expiration date: 31-oct-2025; h4.Device manufacture date: 24-oct-2022.H.6 investigation summary: it was reported there was an infection at the iv insertion area.As a sample was not returned, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 306546, possible lot numbers 2340250, 3031739 and 2297879.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for these lot.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.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.

• Brand Name: BD POSIFLUSH IV FLUSH NORMAL SALINE FILLED 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16966441
• MDR Text Key: 315739935
• Report Number: 1911916-2023-00329
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306546
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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