MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 22GAX1.00IN PRN/EC SLM; INTERVASCULAR CATHETER

Catalog Number 383019

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the intima-ii y 22gax1.00in prn/ec slm experienced defective/damaged tubing and leakage which was noted during use.The following information was provided by the initial reporter: intraoperative intravenous indwelling needle was used in the patient, and fluid leakage was found at the stop fluid clip of the intravenous indwelling needle when the patient returned to the ward after surgery, and the patient was re-given puncture indwelling intravenous needle.

Manufacturer Narrative

This complaint has been identified as a duplicate of mfr report# 3006948883-2019-00986 therefore this mdr should be disregarded.Any information regarding this incident can be found under mfr report # 3006948883-2019-00986.

Event Description

It was reported that the intima-ii y 22gax1.00in prn/ec slm experienced defective/damaged tubing and leakage which was noted during use.The following information was provided by the initial reporter: intraoperative intravenous indwelling needle was used in the patient, and fluid leakage was found at the stop fluid clip of the intravenous indwelling needle when the patient returned to the ward after surgery, and the patient was re-given puncture indwelling intravenous needle.

• Brand Name: INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9451503
• MDR Text Key: 180618840
• Report Number: 3006948883-2019-01058
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 383019
• Device Lot Number: 8262025
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other