MAUDE Adverse Event Report: BD (BECTON DICKINSON AND COMPANY) 0.9% SODIUM CHLORIDE INJECTION USP

Lot Number 734211A

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Fever (1858); Lethargy (2560)

Event Date 04/07/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, i received a shipment of bd sodium chloride injections to flush my picc central line.The lot number was 734211a and ref (b)(4).These saline flushes have been recalled by bd.I used saline flushes a few times a week.My sister received stem cells from me multiple times.On date that she received stem cells was (b)(6) 2018.If you need the other dates for my sister receiving my stem cells, i can get that info from her doctor.I got sick approx (b)(6) 2018 and went to (b)(6) on (b)(6).My symptoms were high fever, yellow-green sputum, cough, lack of appetite.I was diagnosed with pneumonia and given antibiotics.My sister who received my stem cells also got sick and was hospitalized twice.First admission was (b)(6) 2018.She grew klebsiella and enterococcus in her hickman line.She was given antibiotics.Her second admission was (b)(6), 2018.She grew pantoea, (b)(6) and coagulase negative staph in her hickman line.She was given antibiotics.Drs at (b)(6) were stumped because my sister's hickman line grew multiple organisms at one time.Date the person first started taking or using the product: (b)(6) 2018.Stem cell donor for my sister.The info provided above was for myself (b)(6).If you want info about my sister, the stem cell recipient who also got sick let me know so i can provide it.Nothing except saline flushes.Strength: 0.9% percent."did the problem stop after the person reduced the dose or stopped taking or using the product: yes, did the problem return if the person started taking or using the product again: doesn't apply.".

• Brand Name: 0.9% SODIUM CHLORIDE INJECTION USP
• Type of Device: 0.9% SODIUM CHLORIDE INJECTION USP
• Manufacturer (Section D): BD (BECTON DICKINSON AND COMPANY)
• MDR Report Key: 7587382
• MDR Text Key: 110639221
• Report Number: MW5077738
• 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
• Type of Report: Initial
• Report Date: 06/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 734211A
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR
• Patient Weight: 83