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

Catalog Number 38183414

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 06/24/2019

Event Type  Injury  

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 that catheter back out occurred during use with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, "a possible quality deviation of catheter iv bd insyte autoguard, since we had an event in which the product to be introduced presents resistance and, because of this there is the extravasation of blood to the interstitium, besides, the catheter does not offer facility / ability with handling.".

Event Description

It was reported that catheter back out occurred during use with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, "a possible quality deviation of catheter iv bd insyte autoguard, since we had an event in which the product to be introduced presents resistance and, because of this there is the extravasation of blood to the interstitium, besides, the catheter does not offer facility / ability with handling.".

Manufacturer Narrative

H.1.Type of reportable events: serious injury.H.6.Investigation summary: a bd quality engineer was unable to verify the reported complaint.Photos or samples are not available for analysis and because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to verify this complaint as being generated by manufacturing process.Based on the information it may be related to a failure by the user.H3 other text : see section h.10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8796050
• MDR Text Key: 151490466
• Report Number: 9610048-2019-00233
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903818342
• UDI-Public: 30382903818342
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 38183414
• Device Lot Number: 9102723
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other