MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SAF-T EZSET BL STANDARD 25GA.75IN NDL; INTRAVASCULAR CATHETER

Catalog Number 38732614

Device Problems Device Damaged Prior to Use (2284); Structural Problem (2506)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2019

Event Type  malfunction  

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 saf-t ezset bl standard 25ga.75in ndl adapter was found damaged after removing it from the packaging, and would not connect to the syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: "when opening the packaging of the device to perform collection, it was noticed that the adapter was bowed not allowing connection with the syringe.".

Manufacturer Narrative

Investigation: 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 verify this complaint as being generated by manufacturing process.

Event Description

It was reported that the saf-t ezset bl standard 25ga.75in ndl adapter was found damaged after removing it from the packaging, and would not connect to the syringe.The following information was provided by the initial reporter, translated from portuguese to english: "when opening the packaging of the device to perform collection, it was noticed that the adapter was bowed not allowing connection with the syringe.".

• Brand Name: SAF-T EZSET BL STANDARD 25GA.75IN NDL
• 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: 8540569
• MDR Text Key: 142919289
• Report Number: 9610048-2019-00154
• 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
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 38732614
• Device Lot Number: 8298795
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other