MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-24 for HEPARIN LOCK FLUSH SOLUTION, USP 2 USP UNIT/ 2 ML MIH-4422 manufactured by Medefil, Inc..
[118872409]
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.
Patient Sequence No: 1, Text Type: N, H10
[118872410]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423982-2018-00003 |
| MDR Report Key | 7815366 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-24 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2018-07-02 |
| Date Added to Maude | 2018-08-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PRADEEP AGGARWAL |
| Manufacturer Street | 405 WINDY POINT DRIVE |
| Manufacturer City | GLENDALE HEIGHTS IL 60139 |
| Manufacturer Country | US |
| Manufacturer Postal | 60139 |
| Manufacturer Phone | 6306814600 |
| Manufacturer G1 | MEDEFIL, INC. |
| Manufacturer Street | 250 WINDY POINT DRIVE |
| Manufacturer City | GLENDALE HEIGHTS IL 60139 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60139 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEPARIN LOCK FLUSH SOLUTION, USP 2 USP UNIT/ 2 ML |
| Generic Name | HEPARIN LOCK FLUSH SOLUTION, USP |
| Product Code | NZW |
| Date Received | 2018-08-24 |
| Catalog Number | MIH-4422 |
| Lot Number | H218312N |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEFIL, INC. |
| Manufacturer Address | 250 WINDY POINT DRIVE GLENDALE HEIGHTS IL 60139 US 60139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-24 |