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

Model Number	382634
Medical Device Problem Codes	Material Puncture/Hole (1504); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Fda notified: the initial reporter also notified the fda via medwatch # (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "rn placed 20g heplock in right anterior chamber.Iv pulled and iv was found to have the needle sheared through the plastic catheter.Patient did not receive injury.Slight bruising noted at site.".
Additional Manufacturer Narrative
The following fields were updated due to corrections: b.5.Describe event or problem: it was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter during use and failed to retract as a result.The following information was provided by the initial reporter: "rn placed 20g heplock in right anterior chamber.Rn pushes white button to release needle and retraction only occurred partially.Iv pulled and iv was found to have the needle sheared through the plastic catheter.Patient did not receive injury.Slight bruising noted at site." h.6.Imdrf annex a grid: a041001, a0510.
Event or Problem Description
It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter during use and failed to retract as a result.The following information was provided by the initial reporter: "rn placed 20g heplock in right anterior chamber.Rn pushes white button to release needle and retraction only occurred partially.Iv pulled and iv was found to have the needle sheared through the plastic catheter.Patient did not receive injury.Slight bruising noted at site.".
Event or Problem Description
It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter during use and failed to retract as a result.The following information was provided by the initial reporter: "rn placed 20g heplock in right anterior chamber.Rn pushes white button to release needle and retraction only occurred partially.Iv pulled and iv was found to have the needle sheared through the plastic catheter.Patient did not receive injury.Slight bruising noted at site.".
Additional Manufacturer Narrative
H6: investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: 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: 15815759
• Report Number: 1710034-2022-00711
• Device Sequence Number: 20172077
• Product Code: FOZ
• UDI-Device Identifier: 00382903826346
• UDI-Public: (01)00382903826346
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 382634
• Device Catalogue Number: 382634
• Device Lot Number: 2146298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 12/08/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/02/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: White