MAUDE Adverse Event Report: MEDEFIL, INC. HEPARIN IV FLUSH SYRINGE

Catalog Number MIH-3335

Device Problem Crack (1135)

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

Event Date 09/04/2014

Event Type  malfunction  

Event Description

On (b)(4) 2014, medefil, inc., received a letter from fda dated september 30, 2014 regarding the following complaint.(b)(4).Product: heparin iv flush syringe, 100units.Fill volume: 5ml in 12ml syringe.Lot number: h114337n.Expiry date: 05/31/2016.Complainant (b)(6) , pharmacy manager at (b)(6) , stated in the letter that ".Prefilled syringe plunger significantly cracked, and clinician unable to deliver medication".(b)(6) 2014, 9:39am: (b)(6) , director of regulatory affairs at (b)(6) , received a returned call from (b)(6), certified pharmacy technician at (b)(6).(b)(6) , who reports to (b)(6) , stated that ".The nurses had tried using 10 to 11 syringes of this one lot (box of sixty syringes) and all were unusable, cracked plungers, "flimsier" than previous syringes received from medefil, inc.".According to (b)(6) , this was the only box with this lot# in their possession.

Manufacturer Narrative

According to the complainant, the syringe was not used on a patient.Review of the batch record for this lot revealed no incident in the manufacturing of this lot.This is an isolated event since there have been no complaints received for this event.The complaint investigation disclosed that the retain samples revealed that no syringes were found with any defect.The capa is already open for investigating this issue internally.Therefore we are closing this complaint and the further investigation will be covered and recorded under capa.This is an isolated event.The complainant has no additional concerns or more information regarding this event.Based on this information, we will be closing this complaint.However, this issue will be further handled and investigated within the medefil quality management system.

• Brand Name: HEPARIN IV FLUSH SYRINGE
• Type of Device: HEPARIN IV FLUSH SYRINGE
• Manufacturer (Section D): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60194
• Manufacturer (Section G): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60139
• Manufacturer Contact: krupal rewanwar ; 250 windy point drive; glendale heights, IL 60139 ; 6306824600
• MDR Report Key: 4232615
• MDR Text Key: 15365945
• Report Number: 1423982-2014-00001
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: MIH-3335
• Device Lot Number: H114337N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1