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

Catalog Number 381434

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd insyte autoguard have shards of plastic on the catheter.The following information was provided by the initial reporter: please look at each catheter you open before using.Some have found little shards of plastic on the plastic cannula.Please discard these and do not use on the patients!.

Manufacturer Narrative

Investigation results: one photograph was provided for investigation.The photo showed one 20g insyte autoguard iv catheter that was positioned over the needle.A red circle was drawn around the catheter with an arrow pointing to the catheter tubing.Due to the poor image quality, no plastic shards or foreign material were identified on the catheter.As the photograph does not support the complainant¿s description of the reported event, the complaint could not be confirmed.Foreign material may have been introduced during packaging/manufacturing as a result of environmental factors, incoming material, personnel, or processing.To mitigate the occurrence of this type of defect: operators perform cleaning per the quality plan and the bd 5s initiative, good manufacturing practices and gowning are followed, and environmental controls and inspections for foreign matter are performed per the quality control and sampling plans.Investigation conclusion(s): the complaint of ¿foreign matter¿ was not confirmed.Probable root cause(s): a root cause cannot be determined without a confirmed defect.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: PERIPHERAL IV 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18185753
• MDR Text Key: 328707631
• Report Number: 1710034-2023-01332
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814343
• UDI-Public: (01)00382903814343
• 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: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: Health Professional
• Device Catalogue Number: 381434
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1