MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE EXTENSION SET 15 CM (6 IN) 1.14 ML STD BORE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 385101

Device Problem Gas/Air Leak (2946)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported while using bd q-syte extension set 15 cm (6 in) 1.14 ml std bore leakage occurred there was no report of patient impact.The following information was provided by the initial reporter: unable to draw blood, air leakage.

Manufacturer Narrative

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

Manufacturer Narrative

Our quality engineer inspected the 1 sample submitted for evaluation.The reported issues of aspirate / draw (cannot / difficult) and leakage were confirmed upon inspection of the sample.During the inspection a crack was found on the extinction tubing.Bd determined that the cause of the failure was likely attributed to our supplier, however without the batch number a further review into the production records cannot be performed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.H3 other text : see narrative below.

Event Description

No new information received unable to draw blood, air leakage.

• Brand Name: BD Q-SYTE EXTENSION SET 15 CM (6 IN) 1.14 ML STD BORE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17916920
• MDR Text Key: 325445449
• Report Number: 9610847-2023-00281
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851010
• UDI-Public: (01)00382903851010
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1