MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10 INTERVASCULAR CATHETER

Catalog Number 383734

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap) 22ga x 1. 00in 0. 9mm x 25mm. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap) 22ga x 1. 00in 0. 9mm x 25mm experienced leakage at adapter and tubing. The following information was provided by the initial reporter: leakage was found at the end of the extension tube before injection.

• Brand Name: SEE H10
• Type of Device: INTERVASCULAR 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: 11061683
• MDR Text Key: 223458630
• Report Number: 8041187-2020-00863
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PENDING
• 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: 02/18/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383734
• Device Lot Number: 0197307
• 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: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial