MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC; INTRAVASCULAR CATHETER

Catalog Number 383738

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one pegasus bl 22gax1.00in qsyte-capy nonpvc has been found experiencing leakage during use.The following has been provided by the initial reporter: it's noticed that leakage at q-syte (not the diaphragm on the q-syte,not the screw, leakage at conjunction site) and then the infusion set is closed.At this time, the blood is returned to the joint.The patient's blood leaked from the leak.Leaked blood confirmed to be a little.No adverse reaction on patient.

Manufacturer Narrative

Investigation summary: received a used q-syte unit with no packaging material.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Visual examination: the slit of the septum top disk was slightly off-centered.Damage (tears) was observed on the slit.Water leak test: the unit was tested on the actuated and the unactuated positions.Leakage was occurred on both positions.Water leaked out of the vent hole.Visual examination (dissection after leak test): the slit of the bottom disk was also off centered.Damage (tears) on the column wall coincide the bottom slit location.Conclusion(s): indeterminate ¿ although it was confirmed the unit leaked through the tear found on the column wall of the septum, a definite source that caused the tear could not be determined.It is not known if it was caused by the clinician at the user environment or by the manufacturing process.

Event Description

It has been reported that one pegasus bl 22gax1.00in qsyte-capy nonpvc has been found experiencing leakage during use.The following has been provided by the initial reporter: it's noticed that leakage at q-syte(not the diaphragm on the q-syte,not the screw, leakage at conjunction site)and then the infusion set is closed.At this time, the blood is returned to the joint.The patient's blood leaked from the leak leaked blood confirmed to be a little no adverse reaction on patient.

• Brand Name: PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9082937
• MDR Text Key: 178791559
• Report Number: 3006948883-2019-00776
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/02/2022
• Device Catalogue Number: 383738
• Device Lot Number: 9023769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other