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

Catalog Number 381523

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 by clinicians that the catheter hubs on bd insyte¿ autoguard¿ shielded iv catheters are breaking at the junction of the catheter after placement.There was no report of injury or medical intervention.

Manufacturer Narrative

A device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the defect of catheter broken/separated after placement.The peura was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing could not be performed because no samples or photos were received for investigation of this incident.The defect catheter broke/separated after placement; as stated in the product incident report could not be identified or confirmed and root cause could not be determined, as the units described were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7154874
• MDR Text Key: 96124046
• Report Number: 1710034-2017-00527
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815235
• UDI-Public: 30382903815235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 381523
• Device Lot Number: 7219549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• 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