MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN; INTRAVASCULAR CATHETER

Catalog Number 381923

Device Problem Retraction Problem (1536)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported while using bd insyte¿ autoguard¿ winged shielded iv catheter 22ga 1.00in the needle failed to retract.There was no report of patient impact.The following information was provided by the initial reporter: the customer's verbatim report is as follows: (2) the hcp pressed the button, but the needle was not retracted (registered as needle retraction failure).

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 14-apr-2022.H.6.Investigation: our quality engineer inspected sample and photographs submitted for evaluation.Bd received one 22g x 1.00in.Insyte autoguard unit with no documentation to indicate the reference number or lot number.Additionally, four photos were provided for investigation.In the first three photos the unit can be seen in an un-retracted state.The fourth photo shows the same unit with the needle retracted.No media can be seen in any of these photos.The returned unit was similar to the photographed unit; however, black and red media was present inside the grip and barrel.Looking at the provided pictures and the picture taken before decontamination media is not present in those photos.Therefore, it is likely that the media was introduced during the decontamination procedure.Additionally, since three of the provided pictures show the unit in an un-retracted state, it is likely that the unit was not used.Further microscopic inspection found that there was a single scratch on the needle cover, the catheter tubing and needle were not bent, and the needle hub itself was bent.Bending as seen in this unit is known to prevent retraction of the needle.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

Event Description

It was reported while using bd insyte¿ autoguard¿ winged shielded iv catheter 22ga 1.00in the needle failed to retract.There was no report of patient impact.The following information was provided by the initial reporter: the customer's verbatim report is as follows: (2) the hcp pressed the button, but the needle was not retracted (registered as needle retraction failure).

• Brand Name: BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN
• 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: 14164346
• MDR Text Key: 289901107
• Report Number: 1710034-2022-00204
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/05/2022

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
• Device Operator: Other
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 381923
• Device Lot Number: 1144359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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