MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNSPECIFIED BD Q-SYTE LUER ACCESS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problems Pain (1994); Chemical Exposure (2570)

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).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 unspecified bd q-syte luer access was damaged, causing leakage.The following information was provided by the initial reporter, translated from (b)(6): "it was found that the middle of q-syte was broken, and the liquid medicine spilled on the patient's hand, causing discomfort.".

Manufacturer Narrative

Investigation summary : bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h10.

Event Description

It was reported unspecified bd q-syte luer access was damaged, causing leakage.The following information was provided by the initial reporter, translated from chinese: ".It was found that the middle of q-syte was broken, and the liquid medicine spilled on the patient's hand, causing discomfort.".

• Brand Name: UNSPECIFIED BD Q-SYTE LUER ACCESS
• 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: 13079383
• MDR Text Key: 285547259
• Report Number: 9610847-2021-00610
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• 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