FDA Adverse Event Summary report: N

SYRINGE TIP

MDR report key: 8206453 · Received December 28, 2018

Report

Report Number
MW5082706
Date Received
December 28, 2018
Report Date
December 28, 2018
Manufacturer
UNK
Product Code
FMF
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

IN 2018, ACUTE CARE ISMP MEDICATION SAFETY ALERT EDITION, THERE WAS A SAFETY BRIEF REGARDING THE CHOKING HAZARD ASSOCIATED WITH THE RESIDUAL PLASTIC RING AFTER BREAKING THE SEAL ON TAMPER EVIDENT CAPS. WE IDENTIFIED AN ADDITIONAL SAFETY RISK AT OUR INSTITUTION RELATED TO THE PLASTIC RINGS FOR THE CONVERSE SCENARIO WHEREBY THE RING MAY EASILY SLIDE OFF WITHOUT FORCE AND BY GRAVITY ALONE. THE TAMPER EVIDENT CAPS HAVE HISTORICALLY BEEN USED FOR PHARMACY PREPARED SYRINGES AS SUPPLIED TO OUR CATH LAB TO FACILITATE CATHETER IN INSERTION AND REMOVAL VIA THE RADIAL ARTERY. WHEN THEY WERE READY TO BE USED, THE TAMPER EVIDENT CAPS WERE TAKEN OFF BY A CATH LAB NURSE. IN THE CASE OF THE INTERNATIONAL MEDICAL INDUSTRIES REF (B)(4) TAMPER EVIDENT CAP, THE PLASTIC RING VERY EASILY SLIDES OFF THE BARREL OF THE SYRINGE TIP. THERE IS POTENTIAL FOR THE RING PIECE TO FALL INTO AN UNINTENDED LOCATION OR EVEN INTO THE STERILE FIELD. WE HAVE DISCONTINUED THE USE OF THESE CAPS IN AS MUCH AS POSSIBLE THROUGHOUT OUR INSTITUTION INCLUDING THE CATH LAB AND WOULD ADVISE INCREASED CAUTION WITH THIS DELIVERY DEVICE. SEVERITY: CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6), ACCESS NUMBER: (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1044067 SYRINGE TIP SYRINGE PISTON FMF UNK

Patients

Seq Age Sex Outcome Treatment
1