MAUDE Adverse Event Report: BD BD PRE-FILLED NORMAL SALINE SYRINGES; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306500

Device Problem Nonstandard Device (1420)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 12/28/2017

Event Type  Death  

Event Description

Reporter states the syringes her sister was using were contaminated which led to her untimely death.Patient developed c-diff and was in and out of the hospital due to reoccurring infections.The patient was using the device from (b)(6) 2007 - (b)(6) 2018.The reporter received a recall letter on may 9th confirming the device had been contaminated and recalled off the market.

• Brand Name: BD PRE-FILLED NORMAL SALINE SYRINGES
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 7518009
• MDR Text Key: 108600167
• Report Number: MW5077222
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 306500
• Device Lot Number: 715911C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 57 YR