MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD POSIFLUSH HEPARIN ; HEPARIN, VASCULAR ACCESS FLUSH

Device Problem Nonstandard Device (1420)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Nausea (1970)

Event Date 04/22/2018

Event Type  Injury  

Event Description

Pt had four consecutive weeks of becoming ill with diarrhea, nausea and upset stomach within 2 hrs of his weekly ivig on (b)(6) and (b)(6) 2018.Once i looked back on the calendar and my notes, i saw it started on (b)(6).The stomach symptoms, along with lack of appetite, and persistent diarrhea lasted from 2 hrs post each above infusion, until the following tuesday each week.He would then start to feel better and have no symptoms until the next sunday infusion again.This week, using the newly supplied heparin flushes during infusion was the first week without stomach or diarrhea issues, post infusion.We feel it is clear that there was a correlation between the two.Per the recall letter you sent on may 15, we did have both heparin and saline syringes affected in the lots and catalog numbers on the recall sheet.Our nurse kate does not separate shipments by week, but rather empties the new supplies into a larger bag of any overflow supplies every other week, therefore, any older syringes are mixed with the newer ones.I previously discarded the heparin flushes when we spoke last week and am discarding the balance of the saline syringes (other than the harder packaged ref#'s of (b)(4)) today.

• Brand Name: BD POSIFLUSH HEPARIN
• Type of Device: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY ; columbus NE
• MDR Report Key: 7641072
• MDR Text Key: 112565268
• Report Number: MW5078075
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 06/22/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/04/2018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• 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): Other
• Patient Age: 10 YR
• Patient Weight: 30