HYDROMORPHONE HCI CARPUJECT INJECTOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for HYDROMORPHONE HCI CARPUJECT INJECTOR manufactured by Hospira, Inc..

Event Text Entries

[184665791] Carpuject broke off during injection. Diagnosis for use: pain.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093864
MDR Report Key9865094
Date Received2020-03-20
Date of Report2020-03-18
Date of Event2020-03-07
Date Added to Maude2020-03-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameHYDROMORPHONE HCI CARPUJECT INJECTOR
Generic NameADAPTOR, HOLDER, SYRINGE
Product CodeIQG
Date Received2020-03-20
Lot Number10760LL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerHOSPIRA, INC.

Device Sequence Number: 101

Brand Name1MG/ML ML MILLILITRE(S)
Product Code---
Date Received2020-03-20
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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