MAUDE Adverse Event Report: BECTON DICKINSON GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING; INTRAVENOUS EXTENSION TUBING SET

Catalog Number 11532269

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

Material #: 11532269 batch#: 23115345.Verbatim: the bd phaseal optima injector #(b)(6) luered itself off of the iv tubing set bd infusion set#23115345.The customer states it was not a user error as they tried again to see if it would gradually luer itself off and it did.Concern with the luer connection between the iv infusion set and the bd phaseal optima injector not being secure.

• Brand Name: GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING
• Type of Device: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18969539
• MDR Text Key: 338595385
• Report Number: 9616066-2024-00461
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: (01)10885403232343
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11532269
• Device Lot Number: 23115345
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1