MAUDE Adverse Event Report: ELI LILLY AND CO. SYRINGE; SYRINGE, PISTON

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hair Loss (1877); Memory Loss/Impairment (1958); Overdose (1988); Renal Failure (2041); Scar Tissue (2060); Sepsis (2067); Coma (2417); Confusion/ Disorientation (2553); Fluid Discharge (2686)

Event Date 01/20/2018

Event Type  Injury  

Event Description

Reporter stated that when she was trying to administer medication from the prefilled injector, something snapped inside the device and emptied 23 days' worth of medication all at once.Reporter contacted poison control people and stayed home.Reporter said the only thing she witnessed was amber like fluid coming through her bottom.As days went by, the reporter started having symptoms like, confusion, getting sick, sepsis, renal failure, small bowel obstruction, hair loss and ended up in the icu from a coma.She also suffered from memory loss and did not remember anything for about 12 days while in hospital.She said drs were able to reverse most of her conditions except the bowel obstruction issue.Late in (b)(6) she ended up again in er for the bowel obstruction issue and had surgeries to finally take care of the problem.All in all, she had 14 surgeries, 8 of them were abdominal.She also had scar tissues from all the surgeries.She was also saying there is no instructions with the medication packets that explains what the overdose amount is and what to do in the event of an overdose.

• Brand Name: SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ELI LILLY AND CO.
• MDR Report Key: 8032448
• MDR Text Key: 126110511
• Report Number: MW5081000
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Weight: 73