MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD SHIELDED IV CATHETER

Model Number 381823

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter needle would not retract.This was discovered during use.The following information was provided by the initial reporter: after venous puncture using a number 22 non-needled peripheral venous catheter, when activating the safety device to retract the needle, we were not successful.The needle is exposed.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter needle would not retract.This was discovered during use.The following information was provided by the initial reporter: after venous puncture using a number 22 non-needled peripheral venous catheter, when activating the safety device to retract the needle, we were not successful.The needle is exposed.

Manufacturer Narrative

H.6.Investigation summary a physical sample was not available for investigation but bd was provided with four photos of the issue for evaluation.A review of the device history record was performed for the reported lot, 9249652, and no quality issues were found during production.Our quality engineer reviewed the provided photos and found that the needle failed to retract properly.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for investigation a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10169307
• MDR Text Key: 198858069
• Report Number: 9610048-2020-00091
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

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: 07/31/2022
• Device Model Number: 381823
• Device Catalogue Number: 38182314
• Device Lot Number: 9249652
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other