MANIFOLD KIT K09-02334

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-30 for MANIFOLD KIT K09-02334 manufactured by Merit Medical Systems, Inc..

Event Text Entries

[53449233]
Patient Sequence No: 1, Text Type: N, H10

[53449234] During left heart catheterization, the dye chamber would not refill itself and had to be manually refilled multiple times. No harm to patient. Manufacturer response for iv tubing, merit manifold kit (per site reporter): manufacturer was contacted regarding this product and concern for serious patient injury. Voluntary recall initiated. Merit medical notified regarding recent incidents. Replacement product was sent overnight to facility and received.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5913375
• MDR Report Key: 5913375
• Date Received: 2016-08-30
• Date of Report: 2016-08-16
• Date of Event: 2016-08-15
• Report Date: 2016-08-16
• Date Reported to FDA: 2016-08-16
• Date Reported to Mfgr: 2016-08-16
• Date Added to Maude: 2016-08-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MANIFOLD KIT
• Generic Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Product Code: OEQ
• Date Received: 2016-08-30
• Returned To Mfg: 2016-08-16
• Catalog Number: K09-02334
• Lot Number: H973504
• Device Expiration Date: 2019-06-30
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: MERIT MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1600 WEST MERIT PARKWAY SOUTH JORDAN UT 84095 US 84095

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-08-30