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

Catalog Number 38181214

Device Problem Material Rupture (1546)

Patient Problems Skin Irritation (2076); Distress (2329); Discomfort (2330)

Event Date 03/22/2018

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 when having to perform multiple venipunctures due to the "plastic catheter" rupturing on a bd insyte¿ autoguard¿ bc, the patient reported "discomfort, stress, altered vital signs, soft tissue trauma, and bruises on the skin" it was also reported that the patient may have permanent psychic trauma due to the repeated venous punctures."these traumas are related to the involvement of extravascular space, directly injuring the vessel structure and triggering impacts on areas close to it due to extravasation.These traumas were treated and medicine prescribed was polysulfate of mucopolysaccharide (hirudóide) prescribed by the medicine.".

Manufacturer Narrative

Investigation summary: no samples displaying the condition reported were available for examination.We were unable to fully investigate this incident.Review of dhrs revealed all required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling plans.Review disclosed no evidence of the alleged defects as there were no reject activity findings throughout the build of these lots that would impact the outcome of the quality of the product relevant to the defects stated in the pr.Investigation conclusion: relationship of device to the reported incident: indeterminate - without a sample for evaluation and testing there was no physical/mechanical evidence to confirm or support manufacturing process related issues for the reported defect.

• 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: 7465764
• MDR Text Key: 106670737
• Report Number: 9610048-2018-00055
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 38181214
• Device Lot Number: 7293987
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention