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

Catalog Number 383019

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 11/25/2017

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 during use, a bd intima-ii¿ closed iv catheter system malfunctioned as¿ during ct high pressure infusion, the e -tubing broke¿ resulting in blood leakage.There is no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: the customer stated that during ct high pressure infusion, the e-tubing was broken with blood.The customer did provide a sample to aid in the investigation.With the sample provided, bd was able to duplicate the failure mode reported.The production record was reviewed and no non-conformance was noted during the manufacturing of this lot.According to the original complaint information, the returned sample broke when it was used for high pressure injections.A plant simulation of high pvc as an experiment showed that the extension tube of the pvc material did break under high pressure injection causing the broken shape to be similar to that of the reported defect.The investigation was able to confirm the defect was not related to the manufacturing process.

• 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
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7182532
• MDR Text Key: 97800593
• Report Number: 3006948883-2017-00214
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/18/2020
• Device Catalogue Number: 383019
• Device Lot Number: 7265037
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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
• Patient Outcome(s): Other