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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDEFIL, INC. HEPARIN I.V. FLUSH SYRINGE
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MEDEFIL, INC. HEPARIN I.V. FLUSH SYRINGE Back to Search Results
Device Problems Hole In Material (1293); Device Damaged Prior to Use (2284); Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 05/11/2018
Event Type  malfunction  
Event Description
During manual visual inspection of the culled rejects from automated (eisai) inspection of the filled syringes for product: heparin lock flush, lot #h118248n on (b)(6) 2018, thirteen syringes were discovered to have pin holes in the yellow tip caps.Inventory and batch records were reviewed to identify potentially defective yellow tip cap lots and the finished product batches where these yellow tip cap lots were used.It was discovered that the following lots released to the market using same lots of tip cap used in lot #h118248n.Batch number: h118165n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, catalog number: mih-3335; h118174n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118183n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118190n - heparin i.V.Flush syringe; 300 units/3 ml; 3 ml fill in 6 ml syringe, mih-3323; h118191n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118200n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118206n - heparin i.V.Flush syringe; 300 units/3 ml; 3 ml fill in 12 ml syringe, mih-3335; h118216n - heparin i.V.Flush syringe; 300 units/3 ml; 3 ml fill in 12 ml syringe, mih-3333; h118220n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335.Medefil, inc has initiated an investigation for the above mentioned finished product lots that are shipped from our warehouse and the investigation is still underway.
 
Event Description
During manual visual inspection of the culled rejects from automated (eisai) inspection of the filled syringes for product: heaprin lock flush, lot #h118248n on 05/11/2018, thirteen syringes were discovered to have pin holes in the yellow tip caps.Inventory and batch records were reviwed to identify potentially defective yellow tip cap lots and the finished product batches where these yellow tip cap lots were used.It was discovered that the following lots released to the market using same lots of tip cap used in lot #h118248n.H118165n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118174n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118183n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118190n - heparin i.V.Flush syringe; 300 units/3 ml; 3 ml fill in 6 ml syringe, mih-3323; h118191n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118200n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335; h118206n - heparin i.V.Flush syringe; 300 units/3 ml; 3 ml fill in 12 ml syringe, mih-3335; h118216n - heparin i.V.Flush syringe; 300 units/3 ml; 3 ml fill in 12 ml syringe, mih-3333; h118220n - heparin i.V.Flush syringe; 500 units/5 ml; 5 ml fill in 12 ml syringe, mih-3335' medefil, inc has initiated an investigation for the above mentioned finished product lots that are shipped from our warehouse and the investigation is still underway.
 
Manufacturer Narrative
Medefil concluded that there were no activities or conditions in our processes and equipment that could have caused or exacerbated the tip cap pin holes defects.It was therefore concluded that this defect was only caused by the manufacturing activites at the nemera manufacturing site.Medefil performed an inspection on a predetermined sample set of finished product and remaining unused yellow tip caps from the impacted component lots to determine the disposition of affected finished product units and component lots with this event.A "zero acceptance number sampling plan", fifth edition, original c=o sampling plan table with aql = 0.65 was used to sample finished product lots.In addition, a sampling plan was established to inspect the three (3) impacted tip cap component lots based on a ansvasq z1.4-2008 gill aql 0.65 normal sampling plan.The zero acceptance number sampling plan", fifth edition, original c=o sampling plan table with an aql = 0.65 provides a significantly low consumer risk detection plan.The results of the sorting process of 16 finished product batches reported zero (0) leakers, which affirmed the ability of the validated eisai inspection system to identify and remove defective tip caps.In addition, the sorting inspection process of the yellow tip cap lots also reported zero (0) holes in tip caps.This sampling plan in conjunction with the filling process, the validated eisai inspection system and the validate terminal sterilizer, which are detailed below, provided an extremely high level of detection.In addition to the sample results, medefil is confident that our existing processes are capable to ensure that there is no residual patient safety or product quality risk.In addition, since medefil manufactures approximately 6 million units per month, the presence of thirteen (13) defects over this time period would far exceed a six sigma process capability expectation of 3.4 defects per million opportunities.A short description of the existing controls are detailed below: ·during the filling process, the stoppers are inserted into the syringe barrel opening post solution dispensing.As a result of the stopper placement process, if a pin-hole or hole were in the tip cap, the small amount of pressure exerted during stopper placement would result in solution being pushed through the pin hole resulting in a low fill volume.·terminal sterilization- syringes are exposed to high temperature and internal pressure.If a pinhole or a hole existed in the barrel wall, the air to steam pressure balance would change resulting in the discharge of solution through the pin hole.When the solution is lost through a pin-hole, the result would be a low fill volume in the syringes.·eisai inspection system - 1 00% of the filled and terminally sterilized product is inspected for multiple defect types including fill volume.The displacement of solution in the stopper placement process and i or terminal sterilization process, as described above, would result in a low fill volume that would result in rejection by the validated eisai inspection process.- attachment: [investigation results summary and corrective actions.Pdf].
 
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Brand Name
HEPARIN I.V. FLUSH SYRINGE
Type of Device
HEPARIN I.V. FLUSH SYRINGE
Manufacturer (Section D)
MEDEFIL, INC.
250 windy point drive
glendale heights
IL 60139
MDR Report Key7526349
MDR Text Key109106894
Report Number1423982-2018-00002
Device Sequence Number1
Product Code NZW
Combination Product (y/n)N
PMA/PMN Number
K092491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
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