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

Catalog Number 381434

Device Problem Material Integrity Problem (2978)

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

Event Date 05/18/2018

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 and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the safety mechanism of a bd insyte¿ autoguard¿ shielded iv catheter did not pull the needle as fast as it should.There was no report of exposure, injury or medical intervention.

Event Description

It was reported that the safety mechanism of a bd insyte¿ autoguard¿ shielded iv catheter did not pull the needle as fast as it should.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Device/batch history record review: dhr review was performed on the lot number: 8005819.The product was built on afa line 1, from january 12, 2018 thru january 17, 2018.Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the setup and in-process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Qn /sap database review findings: there were no reject activity findings relevant to the defect stated in the complaint associated with the lot number provided for this incident.The peura (end user risk analysis was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing: although observations and testing could not be performed because a sample was not received for investigation, there was a photo submitted for review.The photo displayed a non-retracted 20ga unit and package label with the ref number, lot number, expiration date and the description of the product.The photo submitted for evaluation revealed no mechanical/physical damage that would contribute to the reported defect.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.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
• MDR Report Key: 7573894
• MDR Text Key: 110333498
• Report Number: 1710034-2018-00265
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814344
• UDI-Public: 30382903814344
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 381434
• Device Lot Number: 8005819
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other