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

Catalog Number 381044

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

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 bd insyte¿ autoguard¿ bc shielded iv catheter had a needle that would not retract.The following information was provided by the initial reporter: "the safety of the catheter insyte autogard blood control did not activate.The needle did not retract into the barrel.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 05-may-2022.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used 18g x 1.16in.Insyte autoguard bc pro unit from lot number 1137808.The unit was returned with the needle not retracted.Microscopic inspection found that the grip was adhered to the needle hub.The unit was attempted to be retracted with force, but retraction could not be achieved.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the adhesive dispense process due to station misalignment, part misalignment or adhesive buildup on the nozzle.The dhr for lot 1137808 has been reviewed.One related qn was found.H3 other text : see h.10.

Event Description

It was reported bd insyte¿ autoguard¿ bc shielded iv catheter had a needle that would not retract.The following information was provided by the initial reporter: "the safety of the catheter insyte autogard blood control did not activate.The needle did not retract into the barrel.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14207827
• MDR Text Key: 290069738
• Report Number: 1710034-2022-00213
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381044
• Device Lot Number: 1137808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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