MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INFUSOR, PRESSUR, FOR I.V. BAGS

Catalog Number PIB500

Device Problems Air Leak (1008); Loss of or Failure to Bond (1068)

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

Event Date 05/28/2014

Event Type  malfunction  

Event Description

The user reported that the pressure infusion bag is loosing pressure.The patient came to the cath lab with an acute myocardial infarction.The patient was sent to icu post procedure with the femoral sheath sutured in.The sheath was connected to a pressure bag with heparinized saline to maintain patency in the sheath.The loss of pressure led to clot formation in the sheath.The sheath was removed and replaced.No harm or injury to the patient was reported.

Manufacturer Narrative

Device evaluation: one used device was returned for evaluation.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.The bag was pressure tested and failed the pressure test.The complaint is confirmed.A supplier corrective action has been requested from the manufacturer.

• Brand Name: PRESSURE INFUSION BAG
• Type of Device: INFUSOR, PRESSUR, FOR I.V. BAGS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 3966447
• MDR Text Key: 21493131
• Report Number: 1721504-2014-00131
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: PIB500
• Device Lot Number: I676226
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SHEATH