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

Catalog Number 38833614

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd angiocath¿ iv catheter was defective and leaked.The following information was provided by the initial reporter: the product was used for the peripherical punction, after the punction during the fixation it was observed that the product present leakage in the junction of the catheter's body.

Event Description

It was reported that bd angiocath¿ iv catheter was defective and leaked.The following information was provided by the initial reporter: the product was used for the peripherical punction, after the punction during the fixation it was observed that the product present leakage in the junction of the catheter's body.

Manufacturer Narrative

H.6.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.

• Brand Name: BD ANGIOCATH¿ 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: 8587470
• MDR Text Key: 145267308
• Report Number: 9610048-2019-00172
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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: 04/30/2023
• Device Catalogue Number: 38833614
• Device Lot Number: 8134641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other