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

Model Number 385101

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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) 1.14 ml std bore the tubing deformed during use.There was no report of patient impact.The following information was provided by the initial reporter: tube deformation when priming medication.

Event Description

It was reported while using bd q-syte extension set 15 cm (6 in) 1.14 ml std bore the tubing deformed during use.There was no report of patient impact.The following information was provided by the initial reporter: tube deformation when priming medication.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 25-feb-2022.H6: investigation summary our quality engineer inspected the 1 sample and 2 photos submitted for evaluation.The reported issue was confirmed upon inspection of the sample.During inspection it was seen that the tubing of the sample had burst.Bd determined that the cause of the failure was a result of exceeding the pressure allowed by the product.The product is designed not to leak at pressures below 45 psi or at 20 psi after 100 actuations.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13592236
• MDR Text Key: 286472670
• Report Number: 9610847-2022-00076
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: 30382903851011
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K142527
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 385101
• Device Catalogue Number: 385101
• Device Lot Number: 1082694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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