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

Catalog Number 394501

Device Problem Break (1069)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported while using bd q-syte¿ needle-free connector there was damage.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a broken q-syte.During administration of propofol in the emergency ward, q-syte was broken.

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 11-jan-2023.H6: investigation summary: our quality engineer inspected the 1 unsealed sample and 4 photos submitted for evaluation.The reported issue of component damage - no leak was confirmed upon inspection of the sample.Analysis of the sample showed that the septum was sliced off and the threaded portion of the top body was completely broken off.Bd determined that the cause of the failure could not be determined since the severity of the damage was too high for it to have been caused during manufacturing or during reasonable use of the product.Damage to the product could be caused by manufacturing deficiencies during septum slit formation or during top body loading, but the severity shown in the sample has never been documented in our manufacturing process.There is a possibility that during use damages to the device could occur, but the use would have to be outside of the instructions for use guidelines for the damage observed to have occurred.As a lot number is unknown for this incident, a device history record review cannot be completed.

Event Description

It was reported while using bd q-syte¿ needle-free connector there was damage.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a broken q-syte.During administration of propofol in the emergency ward, q-syte was broken.

• Brand Name: BD Q-SYTE¿ NEEDLE-FREE CONNECTOR
• 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: 16056918
• MDR Text Key: 308532229
• Report Number: 9610847-2022-00503
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• 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