MAUDE Adverse Event Report: E K INDUSTRIES, INC. PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ); FORMALIN, NEUTRAL BUFFERED

Model Number 4499-100, 24499-100, 24499-100

Device Problems Break (1069); Crack (1135); Material Discolored (1170); Product Quality Problem (1506); Component Missing (2306); Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2023

Event Type  malfunction  

Event Description

There are 8 events to report in this report regarding eki industries formalin containers.Event 1: [date redacted]: when stocking procedure room with formalin jars noted that in excess of 30 formalin jars had severely cracked lids.All removed from rooms.Event 2: [date redacted]: opened unused 60ml formalin box and noticed two crack bottles, one halfway open and the other cracked around the seal.Lot# 2215441, exp: [date redacted].Event 3: [date redacted]: two formalin jars were broken.No specimen was in jar.The cover pulls apart in my hand.Event 4: [date redacted]: during procedure in advanced endoscopy several formalin containers noted to have cracked lids.Event 5: [date redacted]: one formalin vial cap was cracked prior to use.One vial was cracked securing it to vial.Lot# 2215441, [date redacted].Event 6: [date redacted]: formalin vial top cracked with it was being secured.No damage to specimen.New top placed on vial.Event 7: [date redacted]: taking formalin out of the new box, lid on crooked and never opened, brand new, jar empty.Event 8: [date redacted]: [redacted name] also reporting contact.Lid cracking with minimal twisting.We have had another incidence today with same lot number.We order them through our medline distributor.Company name on bottle; eki (1-800-283-4244).Event 9: [date redacted]: a new box of unopened formalin containers was opened, and a formalin container was found to have a blue "thing" floating in it.Events 10: formalin jar (40ml) was removed from supply room.Eki 10% formalin fixative noted a small brown particle floating in closed formalin jar.Jar was in supply room.Manufacture letter of investigation attached to this report.Item number 4499100x60ml in events 1, 2, 7, 8, 9, lot# 2215441, exp: [date redacted] for one event.Item number 24499-100x20ml in events 3, 4, 5, 6, lot# 2215441, exp [date redacted] for one event.Item number 24499-100x120ml in event 10, lot #2210801, exp: [date redacted].Manufacturer response for formalin containers, prefilled formalin container 60 ml fill in 120 ml (4 oz.) screw cap warning label / patient information nonsterile (per site reporter).They have investigated some reports, one of which there is an outcome for and the letter is attached, confirming the presence of a bug in the container.

• Brand Name: PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ)
• Type of Device: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): E K INDUSTRIES, INC.; 1403 herkimer st; joliet IL 60432
• MDR Report Key: 16477815
• MDR Text Key: 310606724
• Report Number: 16477815
• Device Sequence Number: 1
• Product Code: IFP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2023

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 Model Number: 4499-100, 24499-100, 24499-100
• Device Lot Number: 2215441, 2210801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2023
• Event Location: Other
• Date Report to Manufacturer: 03/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1