FDA Adverse Event Malfunction Summary report: N

SYRINGE 50-60ML L/L NO NEEDLE

MDR report key: 19115223 · Received April 15, 2024

Report

Report Number
MW5153866
Event Type
Malfunction
Date Received
April 15, 2024
Report Date
April 10, 2024
Manufacturer
BECTON DICKINSON
Product Code
FMF
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

UNSOLICITED: PER CNSS THE PT REPORTED CONTAMINATED SUPPLIES. PT STATES SHE OPENED HER SUPPLIES TODAY AND THERE WAS A SEALED BOX OF 10 CASSETTES. WHEN SHE OPENED THE BOX, ALL THE CASSETTES WERE PARTIALLY OPENED AND WERE MISSING THE RED CAP. SHE PROCEEDED TO UNBOX THE REST OF HER SUPPLIES AND (2) 50CC SYRINGES WERE SEALED AND THERE WAS HAIR SEALED IN WITH THE SYRINGE(S). LOT NUMBER AND EXPIRATION OF CASSETTES AND SYRINGE'S LOT UNKNOWN. PHOTOGRAPHS WERE NOT PROVIDED. PUMP RETURN TRACKING INFORMATION IS NOT AVAILABLE AND NOT APPLICABLE TO EVENT. NO ALARM WAS RELATED TO EVENT THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN AND NOT RELATED TO EVENT. PRODUCT FAULT DID NOT OCCUR IN USE WITH PT. PRODUCT ISSUE DID NOT CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY. CASSETTES AVAILABLE FOR RETURN. UNKNOWN IF SYRINGES ARE AVAILABLE FOR RETURN. PHARMACY IN PROGRESS OF REPLACING. PT HAD BACKUP CASSETTES TO USE. PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION. INFUSION IS LIFE-SUSTAINING. NO MISSED DOSES OR ADVERSE EVENTS REPORTED. OUTCOME: RESOLVED, SUPPLIES BEING REPLACED. NO FURTHER INFO. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL. REF REPORTS: MW5153860, MW5153865.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1232166 SYRINGE 50-60ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON UNK

Patients

Seq Age Sex Outcome Treatment
1 NA Female AMBRISENTAN | CASSETTE MEDI RESERVOIR | PUMP CADD LEGACY| REMODULIN MDV| SILDENAFIL CITRATE | STERILE DILUENT FOR REMODULIN