MAUDE Adverse Event Report: MEDEFIL, INC. HEPARIN I.V. FLUSH SYRINGE; 100 UNITS/ML; HEPARIN I.V FLUSH SYRINGE

Catalog Number	MIH-3323
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently under investigation capa#(b)(4).
Event or Problem Description
(b)(6), reported that they found 5 syringes without labels of heparin i.V flush syringe, lot #h118108n (3 ml in 6 ml syrigne).The syringes are packed in a dispenser and have the outer pouch intact.
Event or Problem Description
(b)(6) rehabilitation hospital of (b)(6) reported that they found 5 syringes without labels of heparin i.V flush syringe, lot #h118108n (3 ml in 6 ml syrigne).The syringes are packed in a dispenser and have the outer pouch intact.
Additional Manufacturer Narrative
1) the batch record for batch #h1181 08n was assessed to evaluate what machine issues were reported during manufacturing.The following labeling machine issues were documented as occurring on (b)(6) 2018: unlabeled syringes being stuck in the labeling machine star wheel.High cross-check rejections which is a rejection for missing labels.Star wheel adjustment problems.After each incident, production resumed after performing the required 1n process check, visual inspection of 40 syringes from each track.2) all retain samples from batch #h118108n were inspected by qa to determine if there were any syringes with missing labels in the retain sample, sealed dispenser boxes.The inspection concluded that there were no syringes found without labels.4) a review of the complaint logs and complaint history found that this is the first complaint for a missing label since the founding of the company.5) the equipment log book for the labeling and plunger rod insertion machine (a-g-prl-002) was reviewed to determine if any machine malfunction was observed during the packaging process for the impacted batch.The following events were recorded: the labeling machine stopped due to the hot stamp coding unit not functioning.The machine was stopped due to a single syringe being stuck in the labeling machine starwheel.Three (3) syringes were discovered with liquid in ribs from the left track during the hourly in process inspection due to the travel track being too tight pressing the sides of the barrel resulting in a slight oval barrel shape allowing liquid to seep passed the stopper rib.6) a review of the maintenance work orders found no major equipment break down events indicating no maintenance was performed on the labelling machine.However, high cross-check rejections (i.E., rejection for missing labels) were reported as cited in the batch record above.After reviewing the labeling process, it was determined that the syringes without a label would only be conveyed into acceptance track if the vision camera system were malfunctioning.However, after reviewing the equipment log book and the batch record, it was determined that the vision system camera was properly functioning and rejecting the syringes as validated.

• Brand Name: HEPARIN I.V. FLUSH SYRINGE; 100 UNITS/ML
• Common Device Name: HEPARIN I.V FLUSH SYRINGE
• Manufacturer (Section D): MEDEFIL, INC.; 405 windy point drive; glendale heights,, IL 60139
• MDR Report Key: 7496837
• Report Number: 1423982-2018-00001
• Device Sequence Number: 2156592
• Product Code: NZW
• UDI-Device Identifier: 30364253333232
• UDI-Public: 30364253333232
• Combination Product (Y/N): N
• PMA/510(K) Number: K092491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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
• Operator of Device: Pharmacist
• Device Expiration Date: 01/12/2019
• Device Catalogue Number: MIH-3323
• Device Lot Number: H118108N
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2018
• Supplement Date Received by Manufacturer: 05/05/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1