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

Catalog Number 381444

Device Problems Fail-Safe Design Failure (1222); Retraction Problem (1536)

Patient Problems Hepatitis (1897); Needle Stick/Puncture (2462)

Event Date 10/26/2017

Event Type  Injury  

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 a bd insyte¿ autoguard¿ shielded iv catheter malfunctioned after use.The safety device failed to retract while the nurse was putting the catheter into the sharps container, this resulted in a needle stick injury.The nurse tested (b)(6).It is unknown what medical intervention was given.

Manufacturer Narrative

Results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the defect of needle retraction failure.Conclusion: confirmation of the defect stated in the pr could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing.Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defects stated in the pir.This root cause is indeterminate.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVENOUS 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: 7060317
• MDR Text Key: 92962525
• Report Number: 1710034-2017-00392
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: 30382903814443
• 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: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 381444
• Device Lot Number: 7192991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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