MAUDE Adverse Event Report: BD 0.9% SODIUM CHLORIDE INJECTION, USP; SALINE, VASCULAR ACCESS FLUSH

Lot Number 9172820

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091)

Event Date 10/23/2019

Event Type  Injury  

Event Description

Patient had implanted port flushed with bd 0.9% sodium chloride for injection from pre-filled syringes bar code (b)(4), she developed lip swelling, hives and urticaria.She was treated with iv diphenhydramine and dexamethasone.She was monitored for approx 1 hr at which time the md and anesthesiologist determined she was stable for the colonoscopy.It was preformed with propofol for sedation without event.Prior to discharge, to deaccess her port, the nurse flushed with the pre-filled saline syringes and capped the port with heparin per our protocol.The patient again developed hives, lip swelling urticaria and tongue swelling which seemed to be worse per the rn the second time.The syringes were all bagged and saved and given to me in the pharmacy department.The pt will be admitted for observation.Pt received 3 different lots of the saline flushes.I could only fit two in below.The 3rd lot was 9172820 exp 05/31/2022.

• Brand Name: 0.9% SODIUM CHLORIDE INJECTION, USP
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 9255471
• MDR Text Key: 164601671
• Report Number: MW5090774
• Device Sequence Number: 3
• Product Code: NGT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/23/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Lot Number: 9172820
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 95