MAUDE Adverse Event Report: MEDEFIL, INC. HEPARIN LOCK FLUSH SOLUTION, USP 2 USP UNIT/ 2 ML

Catalog Number MIH-4422

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

Medefil is vigorously investigating this incident and evaluating all potential sources of hair and other potential contamination.Medefil has established numerous manufacturing and inspection controls.All medefil products are manufactured in a controlled environment with a filling enclosure line that is classified as a class 10,000 and a surrounding filling area that is classified as class 100,000.In addition, all of our products undergo terminal sterilization and 100% inspection by an automated eisai inspection system that is validated to inspect for multiple defect types including particles suspended in the solution.Medefil recognizes the risk that this incident poses to the public and is currently evaluating if any further actions are required.We are currently finalizing our traceability assessment to identify all the components used to manufacture batch h218321n.The components potentially involved in this incident are identified as the syringe 6 ml barrel (specification no.C1004ac), syringe tip cap (specification no.C1008-grac), and plunger stopper (specification no.C1009).Based on these components, a list of potentially affected batches is being created.

Event Description

Medefil received a call from (b)(6) of (b)(6) hospital, (b)(6) on (b)(6) 2018 at 10:57 am cst stating that they had found one syringe (batch h218321n) that contained what appeared to be a hair within the syringe.What appeared to be a hair was caught prior to administration of the syringe contents to the patient.A photo of what appeared to be a hair was also received on the same day.The pharmacist communicated that the object did not move when the syringe was inverted.He further communicated that he peeled back the label to see if it was under the label and it was confirmed that it was not under the label.On august 24, 2018 at 10:30 am, medefil received the syringe with what appeared to be a hair in it.On august 24, 2018 at 12:00 pm, the qc laboratory evaluated syringe contaminant using a 100x microscope at a 10x and 40x magnification and it was confirmed to be a hair.

Manufacturer Narrative

Medefil, inc.Has concluded the investigation and please see the attached file for detailed information.

Event Description

Medefil received a call from (b)(6) hospital, (b)(6) on (b)(6) 2018, at 10:57 am cst stating that they had found one syringe (batch h218321n) that contained what appeared to be a hair within the syringe.What appeared to be a hair was caught prior to administration of the syringe contents to the patient.A photo of what appeared to be a hair was also received on the same day.The pharmacist communicated that the object did not move when the syringe was inverted.He further communicated that he peeled back the label to see if it was under the label and it was confirmed that it was not under the label.On (b)(6) 2018, at 10:30 am, medefil received the syringe with what appeared to be a hair in it.On (b)(6) 2018, at 12:00 pm, the qc laboratory evaluated syringe contaminant using a 100x microscope at a 10x and 40x magnification and it was confirmed to be a hair.

Event Description

Medefil received a call from (b)(6) of (b)(6) hospital, (b)(6) on august 20, 2018 at 10:57 am cst stating that they had found one syringe (batch h218321n) that contained what appeared to be a hair within the syringe.What appeared to be a hair was caught prior to administration of the syringe contents to the patient.A photo of what appeared to be a hair was also received on the same day.The pharmacist communicated that the object did not move when the syringe was inverted.He further communicated that he peeled back the label to see if it was under the label and it was confirmed that it was not under the label.On august 24, 2018 at 10:30 am, medefil received the syringe with what appeared to be a hair in it.On august 24, 2018 at 12:00 pm, the qc laboratory evaluated syringe contaminant using a 100x microscope at a 10x and 40x magnification and it was confirmed to be a hair.

Manufacturer Narrative

Medefil is vigorously investigating this incident and evaluating all potential sources of hair and other potential contamination.Medefil has established numerous manufacturing and inspection controls.All medefil products are manufactured in a controlled environment with a filling enclosure line that is classified as a class 10,000 and a surrounding filling area that is classified as class 100,000.In addition, all of our products undergo terminal sterilization and 100% inspection by an automated eisai inspection system that is validated to inspect for multiple defect types including particles suspended in the solution.Medefil recognizes the risk that this incident poses to the public and is currently evaluating if any further actions are required.We are currently finalizing our traceability assessment to identify all the components used to manufacture batch h218321n.The components potentially involved in this incident are identified as the syringe 6 ml barrel (specification no.C1004ac), syringe tip cap (specification no.C1008-grac), and plunger stopper (specification no.C1009).Based on these components, a list of potentially affected batches is being created.

Event Description

Medefil received a call from (b)(6) children hospital, (b)(6) on august 20, 2018 at 10:57 am cst stating that they had found one syringe (batch h218321n) that contained what appeared to be a hair within the syringe.What appeared to be a hair was caught prior to administration of the syringe contents to the patient.A photo of what appeared to be a hair was also received on the same day.The pharmacist communicated that the object did not move when the syringe was inverted.He further communicated that he peeled back the label to see if it was under the label and it was confirmed that it was not under the label.On august 24, 2018 at 10:30 am, medefil received the syringe with what appeared to be a hair in it.On august 24, 2018 at 12:00 pm, the qc laboratory evaluated syringe contaminant using a 100x microscope at a 10x and 40x magnification and it was confirmed to be a hair.

Manufacturer Narrative

Medefil, inc.Has concluded the investigation and please see the attached file for detailed information.[medefil memo (b)(4).Pdf].

• Brand Name: HEPARIN LOCK FLUSH SOLUTION, USP 2 USP UNIT/ 2 ML
• Type of Device: HEPARIN LOCK FLUSH SOLUTION, USP
• Manufacturer (Section D): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60139
• MDR Report Key: 7815366
• MDR Text Key: 118872409
• Report Number: 1423982-2018-00003
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 10364253444224
• UDI-Public: 0110364253444224
• Combination Product (y/n): N
• PMA/PMN Number: K092491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: MIH-4422
• Device Lot Number: H218312N
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 08/20/2018; 08/20/2018; 08/20/2018
• Supplement Dates FDA Received: 09/05/2018; 09/14/2018; 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1