MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381033

Device Problem Contamination (1120)

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

Event Date 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd insyte¿ autoguard¿ iv catheter experienced foreign matter on device catheter.The following information was provided by the initial reporter: the customer reported that a fibrous fm was found on the catheter of iagbc.

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one unsealed catheter and needle cover from a 20ga x 1.00in.Insyte autoguard bc unit.Additionally, five photos were provided.One of the photos provided displayed a black spot that appears to be on the catheter tubing.There also appears to be some clear foreign matter possibly gel or lubricant on the catheter.Only the catheter and the needle cover were provided physically.Microscopic analysis did not discover the black dot that was in the provided photo, but the clear matter was present as well as an orange string like foreign matter and some red spots.The sample was sent spectral analysis but was unable to get any results on exactly what the foreign matter was.The reported issue was confirmed however we were unable to determine a root cause.

Event Description

It was reported that the bd insyte¿ autoguard¿ iv catheter experienced foreign matter on device catheter.The following information was provided by the initial reporter: the customer reported that a fibrous fm was found on the catheter of iagbc.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16483394
• MDR Text Key: 311240256
• Report Number: 1710034-2023-00180
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

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: 381033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/04/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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