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U.S. Department of Health and Human Services

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

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MEDEFIL, INC. HEPARIN LOCK FLUSH SOLUTION, USP 2 USP UNIT/ 2 ML Back to Search Results
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].
 
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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 Key7815366
MDR Text Key118872409
Report Number1423982-2018-00003
Device Sequence Number1
Product Code NZW
UDI-Device Identifier10364253444224
UDI-Public0110364253444224
Combination Product (y/n)N
PMA/PMN Number
K092491
Number of Events Reported1
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 Date06/30/2020
Device Catalogue NumberMIH-4422
Device Lot NumberH218312N
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/20/2018
Initial Date FDA Received08/24/2018
Supplement Dates Manufacturer Received08/20/2018
08/20/2018
08/20/2018
Supplement Dates FDA Received09/05/2018
09/14/2018
11/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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