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

Catalog Number 388335

Device Problem Material Integrity Problem (2978)

Patient Problem Edema (1820)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 the bd angiocath¿ autoguard¿ shielded iv catheter used on the patient caused hardening and edema at the puncture site.Occurrence happened after use.There was no report of exposure or injury noted.

Manufacturer Narrative

Investigation summary: our 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 confirm this complaint as being generated by manufacturing process.Investigation conclusion: based on the investigation results to date the root cause was not determinate for the defect described in this complaint.

Event Description

It was reported that the bd angiocath¿ autoguard¿ shielded iv catheter used on the patient caused hardening and edema at the puncture site.Occurrence happened after use.There was no report of exposure or injury noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention.Device single use?: no.Device returned to manufacturer: no.This supplemental mdr also corrects the event description: it was reported that the bd angiocath¿ autoguard¿ shielded iv catheter used on the patient caused hardening and edema at the puncture site.The patient returned to the hospital presenting complaints at the puncture site.

Event Description

It was reported that the bd angiocath¿ autoguard¿ shielded iv catheter used on the patient caused hardening and edema at the puncture site.The patient returned to the hospital presenting complaints at the puncture site.

• Brand Name: BD ANGIOCATH¿ 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: 7692855
• MDR Text Key: 114139783
• Report Number: 9610048-2018-00087
• Device Sequence Number: 1
• Product Code: FOZ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 388335
• Device Lot Number: 7300939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention