MAUDE Adverse Event Report: IAG BC PRO GLOBAL GRAY 16GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number 381054

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that iag bc pro global gray 16ga x 1.16in had air bubbles and the samples were hemolyzed.The following information was provided by the initial reporter: air bubbles appeared when the catheter was used for small blood flows, resulting in hemolyzed samples.

Event Description

It was reported that iag bc pro global gray 16ga x 1.16in had air bubbles and the samples were hemolyzed.The following information was provided by the initial reporter: air bubbles appeared when the catheter was used for small blood flows, resulting in hemolyzed samples.

Manufacturer Narrative

H.6.Investigation: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Dhr could not be performed due to unknown lot#.H3 other text : see h.10.

• Brand Name: IAG BC PRO GLOBAL GRAY 16GA X 1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12297831
• MDR Text Key: 265801245
• Report Number: 1710034-2021-00680
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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
• Device Operator: Other
• Device Catalogue Number: 381054
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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