MAUDE Adverse Event Report: IMS LIMITED MORPHINE SULFATE INJECTION, USP; SYRINGE, PISTON

Lot Number L1090H0

Device Problems Crack (1135); Leak/Splash (1354); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

Patient-controlled analgesia (pca) syringe was dropped while in box.Appeared intact except for a chip out of inner barrel below level of use.Nurse attached syringe to pump and iv tubing per policy.Patient required increasingly higher doses of pain medication.When syringe was removed from pump, it was noted that the inner barrel with had multiple cracks and medication inside was on the outer plastic barrel.

• Brand Name: MORPHINE SULFATE INJECTION, USP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): IMS LIMITED; 886 santa anita ave; south el monte CA 91733
• MDR Report Key: 12480464
• MDR Text Key: 271662763
• Report Number: 12480464
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2021,06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: L1090H0
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5110 DA
• Patient Weight: 36