MAUDE Adverse Event Report: BD HEPARIN FLUSH

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Inflammation (1932); Swelling (2091)

Event Date 03/13/2018

Event Type  Injury  

Event Description

The pt is a (b)(6) with severe hemophilia a with an implantable port for administration of recombinant clotting factor.He developed bacteremia with serratia marcescens and had to undergo port removal.Typically, his port is infused with clotting factor several times a week, and the port is flushed with heparin prior to de-access.We received notification from bd regarding a heparin flush recall that included lot numbers which had been given to our pt.The recall was due to concern regarding serratia marcescens contamination.The pt has severe hemophilia a with an inhibitor.He was receiving regular factor infusions (immune tolerance induction, daily factor infusions plus daily infusions of factor for prophylaxis).He developed a hematoma over his port in (b)(6), which eventually resolved.He continued to have problems with his port throughout the winter.The area was frequently inflamed and swollen.It was thought that he either had an unresolved hematoma or had developed an infection.As his port is critical for his medication administration, we worked to keep his port in.While awaiting the port area to heal (when we're presuming it was a hematoma), he did not receive factor infusions and developed a joint bleed which required hospital admission in (b)(6) 2018.He then developed a blister like lesion over his port in (b)(6) 2018 which prompted the port removal.The removal of the post resulted in losing iv access for this pt and a switch to a different product to treat his hemophilia - hemlibra.The admission for his port removal was 3 days.The pt was treated with oral antibiotics after initial iva antibiotics.If he would not have had an infection in his port, he would have remained on his factor and not switched medications (to a new medicine that was newly fda approved but my plan was to wait for a few months of add'l data before switching products).Further, if he would not have had a port infection, i would have kept the port in for easy iv access for at least 2 more years.

• Brand Name: HEPARIN FLUSH
• Type of Device: HEPARIN FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 7471919
• MDR Text Key: 107021846
• Report Number: MW5076827
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 4 YR
• Patient Weight: 20