MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE EXTENSION SET 15 CM (6 IN) 0.34 ML MICRO BORE; INTRAVASCULAR ADMINISTRATION SET

Model Number 385102

Device Problems Leak/Splash (1354); Incomplete or Inadequate Connection (4037)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd q-syte extension set 15 cm (6 in) 0.34 ml micro bore leakage occurred approximately 20 times.There was no report of patient impact.The following information was provided by the initial reporter: the head nurse of the pediatric department of the hospital reported that the nurses in the department frequently found blood and fluid leakage at the connection between the needle-free infusion connector and the extension tube during the indwelling needle infusion operation in (b)(6) 2022, which led to the need for replacement and even occupational exposure.

Manufacturer Narrative

H6: investigation: our quality engineer inspected the 2 videos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A sample is required to determine a root cause of the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported while using bd q-syte extension set 15 cm (6 in) 0.34 ml micro bore leakage occurred approximately 20 times.There was no report of patient impact.The following information was provided by the initial reporter: the head nurse of the pediatric department of the hospital reported that the nurses in the department frequently found blood and fluid leakage at the connection between the needle-free infusion connector and the extension tube during the indwelling needle infusion operation in (b)(6) 2022, which led to the need for replacement and even occupational exposure.

• Brand Name: BD Q-SYTE EXTENSION SET 15 CM (6 IN) 0.34 ML MICRO 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13482855
• MDR Text Key: 285771629
• Report Number: 9610847-2022-00050
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851028
• UDI-Public: 30382903851028
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 385102
• Device Catalogue Number: 385102
• Device Lot Number: 1082697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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