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

Model Number 381433

Device Problem Contamination (1120)

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

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

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 peripheral iv catheter insyte¿ autoguard¿ experienced foreign matter contamination.The following information was provided by the initial reporter: has a black speck in the packaging.

Event Description

It was reported that the bd peripheral iv catheter insyte¿ autoguard¿ experienced foreign matter contamination.The following information was provided by the initial reporter: has a black speck in the packaging.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 13-oct-2022.H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one sealed 20g x 1.00in.Insyte autoguard unit from lot number 2192123.Additionally, two photos were provided for investigation.A gross visual inspection found that a black speck of foreign material (fm) was loose inside the packaging.The reported issue of foreign matter was confirmed, and the cause appeared to be related to the packaging process during manufacturing.The material found was likely polyethylene, which is used in the packaging material.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD PERIPHERAL IV CATHETER INSYTE¿ AUTOGUARD¿
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15580938
• MDR Text Key: 302600514
• Report Number: 1710034-2022-00590
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814336
• UDI-Public: 00382903814336
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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 Model Number: 381433
• Device Catalogue Number: 381433
• Device Lot Number: 2192123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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