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

Catalog Number 381833

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/06/2022

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 the bd insyte¿ autoguard¿ iv catheter's safety mechanism failed to retract the needle and the nurse pricked their finger on it, requiring blood testing per protocol.The following information was provided by the initial reporter, translated from french: "during the insertion of a catheter, when removing the mandrel, one of our nurses tried to activate the catheter safety.However, the mechanism did not work, the chuck did not retract.The patient thought the procedure was over, moved and the nurse pricked her finger with the catheter.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 12-may2022 h6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one sealed 20g x 1.00in.Insyte autoguard unit from lot number 1222254.A gross visual inspection did not find any damage to the components.The unit was functionally tested for retraction.The unit successfully retracted.The reported issue could not be confirmed.The returned unit provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in the report.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

Event Description

It was reported that the bd insyte¿ autoguard¿ iv catheter's safety mechanism failed to retract the needle and the nurse pricked their finger on it, requiring blood testing per protocol.The following information was provided by the initial reporter, translated from french: "during the insertion of a catheter, when removing the mandrel, one of our nurses tried to activate the the catheter safety.However, the mechanism did not work, the chuck did not retract.The patient thought the procedure was over, moved and the nurse pricked her finger with the catheter.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14224617
• MDR Text Key: 290289275
• Report Number: 1710034-2022-00217
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381833
• Device Lot Number: 1222254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• 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): Required Intervention