MAUDE Adverse Event Report: IAG BC PRO GRN 18GA X 1.16IN; CATHETER

Model Number	392544
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that iag bc pro grn 18ga x 1.16in leaked.The following information was provided by the initial reporter: it is reported customer experienced leakage.Verbiage received, i was called to the patient's room and blood was every where.The port on the iv had fallen off and the iv was backflowing blood all over herself, her bed, and the floor.The iv pump was turned off, pressure was applied and the part was placed back on the iv where it had been misplaced.The patient was cleaned up and her bedding and gown were changed out.
Event or Problem Description
It was reported that iag bc pro grn 18ga x 1.16in leaked.The following information was provided by the initial reporter: it is reported customer experienced leakage.Verbiage received, i was called to the patient's room and blood was every where.The port on the iv had fallen off and the iv was backflowing blood all over herself, her bed, and the floor.The iv pump was turned off, pressure was applied and the part was placed back on the iv where it had been misplaced.The patient was cleaned up and her bedding and gown were changed out.
Additional Manufacturer Narrative
Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly. our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: IAG BC PRO GRN 18GA X 1.16IN
• Common Device Name: CATHETER
• MDR Report Key: 12253811
• Report Number: 1710034-2021-00642
• Device Sequence Number: 4066520
• Product Code: FOZ
• UDI-Device Identifier: 00382903925445
• UDI-Public: 00382903925445
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: Other
• Device Model Number: 392544
• Device Catalogue Number: 392544
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1