FDA Adverse Event Summary report: N

DIPHENHYDRAMINE HCK, DIPHENHYDRAMINE

MDR report key: 8483073 · Received April 3, 2019

Report

Report Number
MW5085583
Date Received
April 3, 2019
Report Date
January 22, 2019
Product Code
---
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE IMPLEMENTATION OF THE NEW BD SIMPLIST SYRINGES DURING DRUG SHORTAGES HAS LED TO ERRORS IN OUR HOSP. PREVIOUSLY WITH HYDROMORPHONE PREFILLED SYRINGES AND NOW WITH DIPHENHYDRAMINE PREFILLED SYRINGES. THE PLUNGER OF THE SIMPLIST SYRINGE MUST HAVE PRESSURE MAINTAINED BY THE ADMINISTERING PERSON THROUGHOUT THE ADMINISTRATION. IF PRESSURE IS NOT KEPT ON THE SYRINGE, THE PLUNGER CAN POP OUT THUS SPRAYING OR LEAKING DRUG. AFTER CONTACTING THE MFR, THEIR RESPONSE WAS AN INFOGRAPHIC EXPLAINING THAT PRESSURE MUST ALWAYS BE KEPT ON THE SYRINGE. THE CONCERN IS THE MEDICATIONS BEING ADMINISTERED THROUGH THESE SYRINGES ARE SOMETIMES GIVEN VIA SLOW PUSHES OVER 5-15 MINS. NURSES WILL OFTEN COMPLETE OTHER SMALL TASKS AND PUSH A SMALL AMOUNT AT A TIME, NOT MAINTAINING CONSTANT PRESSURE. IF THIS OCCURS, THERE IS A HIGH RISK OF THE PLUNGER POPPING OUT OF THE SYRINGE AND ERRORS OCCURRING. SEVERITY: CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
270906 DIPHENHYDRAMINE HCK, DIPHENHYDRAMINE ---

Patients

Seq Age Sex Outcome Treatment
1