MAUDE Adverse Event Report: SEE H10; INTRAVASCULAR CATHETER

Model Number 382512

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Hepatitis (1897); Nausea (1970)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Medical device brand name: bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in (0.7 x 19 mm).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in (0.7 x 19 mm) was involved with a patient experiencing serious injury in the form of diarrhea, hepatitis, and nausea.It has not been specified whether medical intervention was administered.The following information was provided by the initial reporter: diarrhea, hepatitis, nausea, insufficient information.

Manufacturer Narrative

H6: investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were 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.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in (0.7 x 19 mm) was involved with a patient experiencing serious injury in the form of diarrhea, hepatitis, and nausea.It has not been specified whether medical intervention was administered.The following information was provided by the initial reporter: diarrhea, hepatitis, nausea, insufficient information.

• Brand Name: SEE H10
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12330969
• MDR Text Key: 266867203
• Report Number: 1710034-2021-00713
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825128
• UDI-Public: 30382903825128
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382512
• Device Catalogue Number: 382512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• 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
• Patient Outcome(s): Other