MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383408

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/10/2018

Event Type  Injury  

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 with the use of the bd intima-ii¿ closed iv catheter system there was an issue with the catheter being broken.It was stated ¿the patient was a (b)(6) old man or woman, entered the hospital for operation because of fracture.On (b)(6), the patient began to use catheter, the punctured point was on the right-hand.No abnormality was found after infusion on 12:00 am of (b)(6).When nurse prepared to infusion and flush the catheter on 17: 00 pm, nurse found water exudate from application and removed the application and found catheter broken.Then scanned on the patient on 18:00 pm and found blurred image in the 1/3 right- arm of patient.The patient was transferred to shanxi other hospital to find the broken part.¿.

Manufacturer Narrative

A representative sample was received for the purpose of our investigation a photo was received for the purpose of our investigation.The investigators were able to observe the reported failure mode in the photo provided.The batch record was reviewed, no related abnormalities were found.Investigation conclusion: investigators noted that the photo shows the catheter had been broken from at its root, and a top down view of the unit shows that the remaining portion of the catheter is not round but rather deformed.The complaint states that the catheter was broken on the second day, but behaved normally for 1 day after infusion.Because the catheter functioned normally immediately following infusion it is speculated that the failure mode did not occur as a result of the manufacturing process.However the root cause cannot be finalized without the return of the damaged unit.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 7484550
• MDR Text Key: 107314126
• Report Number: 3006948883-2018-00066
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/23/2020
• Device Catalogue Number: 383408
• Device Lot Number: 7142043
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR