MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Q-SYTE EXT SET, LUER-LOK 6 IN STD BORE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that q-syte ext set, luer-lok 6 in std bore cracked and leaked.The following information was provided by the initial reporter: q syte tubing that cracked in our medical department.This is not the first time this has happened.The line broke when fluid was flowing through at 4ml/sec.
Event or Problem Description
It was reported that q-syte ext set, luer-lok 6 in std bore cracked and leaked.The following information was provided by the initial reporter: q syte tubing that cracked in our medical department.This is not the first time this has happened.The line broke when fluid was flowing through at 4ml/sec.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of damaged tubing was received from the customer.A photo and sample were provided to aid in the investigation of this defect.During inspection of the photo and sample, damage was observed on the silicone material.A device history record review was completed by our quality engineer team for provided lot number 0027184.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.The root cause for this damage is using the set at pressures that exceed the pressure limit stated in the instructions.H3 other text : see h10.

• Brand Name: Q-SYTE EXT SET, LUER-LOK 6 IN STD BORE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11572646
• Report Number: 9610847-2021-00116
• Device Sequence Number: 4352498
• Product Code: FPA
• UDI-Device Identifier: 00382903851010
• UDI-Public: 00382903851010
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 385101
• Device Lot Number: 9231442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1