MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE; HEPARIN, VASCULA ACCESS FLUSH

Lot Number 709572N

Device Problem Nonstandard Device (1420)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 10/17/2017

Event Type  Injury  

Event Description

Hospitalization due to central line infection in (b)(6) 2017.Pt was given iv antibiotics and had central line removed and replaced.At the time around this incident, pt was using bd heparin lock syringes with a reference/lot number that were later identified in a recall in april of 2018.Blood cultures were positive for bacteria mentioned in recall notice.Strength: 10 iu international unit(s); dose or amount: 5ml millilitre(s); frequency: as needed; route: intravenous bolus; therapy duration: 3 months.Diagnosis or reason for use: to keep central iv access patent.

• Brand Name: BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
• Type of Device: HEPARIN, VASCULA ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 7689229
• MDR Text Key: 114053444
• Report Number: MW5078370
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 08290306510
• UDI-Public: 08290-3065-10
• Combination Product (y/n): N
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/04/2018
• Device Lot Number: 709572N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• 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: 63 YR
• Patient Weight: 59