MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA II¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 383403

Device Problems Fluid/Blood Leak (1250); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 nurse found a kink in the bd intima ii¿ iv catheter near the pinch clamp.On the second day of infusion the nurse noticed normal saline leak from the kinked location.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: a sample was received for the purpose of our investigation.Bd was able to observe the reported failure mode in the sample provided.The tubing of the returned sample was broken about 70mm away from the pp luer.The damage is triangular in shape and the extension tubing had compression marks.Because the unit behaved as expected for the first two days the root cause could not be finalized.The batch record was reviewed, no related abnormalities were found.Investigation summary: the unit behaved as expected for the first two days the root cause could not be finalized.

• Brand Name: BD INTIMA II¿ IV CATHETER
• 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: 7466097
• MDR Text Key: 107204362
• Report Number: 3006948883-2018-00053
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K143610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 383403
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other