MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD SODIUM CHLORIDE 0.9% 10ML POSIFLUSH; SALINE, VASCULAR ACCESS FLUSH

Lot Number 3355044

Patient Problem Unspecified Infection (1930)

Event Date 04/05/2024

Event Type  Injury  

Event Description

Received 2 new boxes of bd 10ml 0.9% sodium chloride posiflush syringes from (b)(6) as sterile flush for picc (peripherally inserted central catheter) line antibiotic infusion.Each box lots # 3332180 and 3355044 originated from the franklin lakes, nj plant product number 8290-306546 both lots were cloudy.My wife received several injections of these fluid before we noted the cloudiness.We have gone to (b)(6) hospital to get quality saline solution.We are concerned that my wife's medical condition, now fighting a full body staph infection may have been compromised.We have retained the subject lots for testing.I can be reached at (b)(6) regards, (b)(6).Only field observation of cloudiness which has been forwarded to our nursing services and the manufacturer.Warnings require not to use product if cloudy.As before and after picc (peripherally inserted central catheter) antibiotic line flush for treatment.Reference report: mw5153670.

• Brand Name: BD SODIUM CHLORIDE 0.9% 10ML POSIFLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 19078292
• MDR Text Key: 339957307
• Report Number: MW5153671
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/06/2024

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 Lot Number: 3355044
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MEDICATION.; OXYCODONE.; PICC FOR INFUSION.; TYLENOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White