MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEGASUS YEL 24GA X 0.75IN QSYTE-CAP Y INTRAVASCULAR CATHETER

Catalog Number 383714

Device Problem Volume Accuracy Problem (1675)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).

Event Description

It was reported that a pegasus yel 24ga x 0. 75in qsyte-cap y had a damaged connector at an unspecified time. The following was reported by the initial reporter: "when package was opened, it was found that the joint was cracked and damaged. Google translation: when fei q was disassembled, it was found that the q plug connector was cracked and damaged. The batch complained about two cases of joints falling off on monday, and on wednesday, the gastroenterology department complained that the joints were broken when they were disassembled.

• Brand Name: PEGASUS YEL 24GA X 0.75IN QSYTE-CAP Y
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11061847
• MDR Text Key: 223606636
• Report Number: 8041187-2020-00868
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 383714
• Device Lot Number: 0055001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial