MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ MICRO BORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 385102

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd q-syte¿ micro bore extension set the septum was unglued/lifts at rim and there was discoloration of the device.The septum event occurred 5 times.The discoloration event occurred 5 times.The following information was provided by the initial reporter."the nurse reported the joint of q-syte product was yellow and the diaphragm was depressed before use.".

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes.Returned to manufacturer on: 2021-09-24.H6: investigation summary: bd received a sample and video submitted for evaluation.The reported issue of septum defective/damaged was confirmed but discoloration was not upon inspection of the sample and video.There are several potential manufacturing root causes that could have occurred, but they cannot be confirmed since the product was returned used.Since the device was used, improper use cannot be ruled out as a potential root cause.It is recommended prior to the use of every bd device to read the instructions for use documentation to ensure the device is used in a manner that results in the least amount of user failures.A device history record review was not performed since no lot number was reported.

Event Description

It was reported when using the bd q-syte¿ micro bore extension set the septum was unglued/lifts at rim and there was discoloration of the device.The septum event occurred 5 times.The discoloration event occurred 5 times.The following information was provided by the initial reporter."the nurse reported the joint of q-syte product was yellow and the diaphragm was depressed before use.".

• Brand Name: BD Q-SYTE¿ MICRO BORE EXTENSION SET
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12543025
• MDR Text Key: 273681973
• Report Number: 9610847-2021-00466
• 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: 11/05/2021

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: Health Professional
• Device Model Number: 385102
• Device Catalogue Number: 385102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 12/02/2021
• 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