MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ NEEDLE-FREE CONNECTOR STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number 385100

Device Problems Complete Blockage (1094); Gas/Air Leak (2946); Air/Gas in Device (4062)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported that the bd q-syte¿ needle-free connector stand-alone device had issues with an air intake with lot # 1348352 and an unknown lot #.Lot# 1348352 also had an occurrence were it was unable to flush.The following information was provided by the initial reporter, translated from french to english: detection of an air intake at the level of the suction return valve, leading to the appearance of air in the extracorporeal circuit.Problem with the non-return valve on the patient's catheter: impossible to inject to flush when there is no problem with aspiration.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1348352.Medical device expiration date: 31-oct-2026.Device manufacture date: 10-jan-2022.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.There was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

The following fields were updated due to additional information: h6: investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported that the bd q-syte¿ needle-free connector stand-alone device had issues with an air intake with lot # 1348352 and an unknown lot #.Lot# 1348352 also had an occurrence were it was unable to flush.The following information was provided by the initial reporter, translated from french to english: detection of an air intake at the level of the suction return valve, leading to the appearance of air in the extracorporeal circuit.Problem with the non-return valve on the patient's catheter: impossible to inject to flush when there is no problem with aspiration.

• Brand Name: BD Q-SYTE¿ NEEDLE-FREE CONNECTOR STAND-ALONE DEVICE
• 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: 15481046
• MDR Text Key: 306411532
• Report Number: 9610847-2022-00362
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: (01)30382903851004
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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