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

Catalog Number 38183414

Device Problem Material Rupture (1546)

Patient Problems Extravasation (1842); Tissue Damage (2104); Distress (2329); Discomfort (2330)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

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: photos or samples are not available for analysis so our quality engineer was unable to verify the reported complaint.Dhr review: as this is a reportable complaint, lot: 7335854 was analyzed and no records of data that could lead to the incident in question were evidenced.Qn/ ncmr review: there are no quality notification (qn) or non-conformity report records that lead to this condition, for the lots involved in this complaint.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.Additional investigations found when there was difficulty in the use of the product by the customer it was not a failure arising from the manufacturing of the product.Based on the information contained in this complaint it may be determined that the root cause is related to failure by the user to use the product.Complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.

• 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: 7468658
• MDR Text Key: 106746729
• Report Number: 9610048-2018-00054
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• 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: 05/07/2018

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: 09/30/2020
• Device Catalogue Number: 38183414
• Device Lot Number: 7335854
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention