MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE 15CM MACRO BORE TRI-EXT SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 385156

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that bd q-syte 15cm macro bore tri-ext set remains kinked after clamping.The following information was provided by the initial reporter: the lumen is getting kinked due to multiple clamping sequences due to which the flow rate is affected (b)(6) 2024: may i know what erroneous results are seen? no.Date of occurrence the customer didn't disclose and was not aware on the exact date.Is there any serious injury occurred to patient? no.

Manufacturer Narrative

E.Address over allowable characters: (b)(6).H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

Investigation results: a device history record review was completed by our quality engineer team for provided material number 385156 and lot number 3184296.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

No additional information.

• Brand Name: BD Q-SYTE 15CM MACRO BORE TRI-EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18966290
• MDR Text Key: 338616380
• Report Number: 1710034-2024-00216
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851560
• UDI-Public: (01)00382903851560
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K142527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 385156
• Device Lot Number: 3184296
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1