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

Model Number 381812

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2020

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.(b)(4).

Event Description

It was reported that there was a mix of product with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: after opening the number 24 intravenous device box, we see a different color device (apparently number 22).

Event Description

It was reported that there was a mix of product with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, translated from portuguese to english: after opening the number 24 intravenous device box, we see a different color device (apparently number 22).

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0027243, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that a 24 gauge and a 22 gauge unit were packaged together.Based off the provided photo the engineer was able to verify the reported failure mode.It was determined that this was most likely an operator error that occurred during the packaging process.A training was issued to all packaging personnel to raise awareness of this issue and prevent recurrence.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10538702
• MDR Text Key: 209174711
• Report Number: 9610048-2020-00126
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: 381812
• Device Catalogue Number: 38181214
• Device Lot Number: 0027243
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other