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

Catalog Number 381423

Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

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 that during use, a bd insyte¿ autoguard¿ shielded iv catheter malfunctioned as the product was found "difficult to retract easily or if at all".There was no report of injury or medical intervention reported.

Manufacturer Narrative

Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the 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.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.Samples were received for evaluation by our quality engineer team.They received 11 unused iag 22ga units in sealed packages from the lot number 7261882.The actual unit described in the incident report was not returned for evaluation.Visual/microscopic examination showed there was no mechanical/physical damage to any of the components (spring, needle hub, or grips) or evidence of adhesive on the buttons or hubs.Functional test (needle retraction) was performed and showed the retraction was successful, no delayed reaction was observed.The returned units provided for evaluation met and performed per the required manufacturing specifications.As there was no definite physical or mechanical evidence that supported manufacturing process related issues for the defect observed in this incident, a root cause could not be determined.The defect needle retraction failure; as stated as the reported code was not confirmed with the returned unit.The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced, per the pir.A formal corrective action will not be initiated at this time.A manufacturing related root cause could not be identified.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: 7144163
• MDR Text Key: 95973783
• Report Number: 1710034-2017-00493
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814238
• UDI-Public: 30382903814238
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 381423
• Device Lot Number: 7261882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• 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