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

Catalog Number 383406

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: 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 leakage occurred with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: patients due to insufficient cerebral blood supply, the left and right sides, the morning of (b)(6) 2019, and get to the patients with closed venous indwelling needle enhanced ct examination of intravenous fluids, in use process, strict aseptic operation, including blood back to smoking, and sodium chloride injection infusion smoothly, without any exception, during intravenous infusion is about 20 ml needle on one-piece rubber cap off, causing the situation of the patients, blood leakage of liquids immediately adopt measures to pull out the needle and oppression hemostasis, comfort to the patients.

Event Description

It was reported that leakage occurred with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: patients due to insufficient cerebral blood supply, the left and right sides, the morning of (b)(6) 2019, and get to the patients with closed venous indwelling needle enhanced ct examination of intravenous fluids, in use process, strict aseptic operation, including blood back to smoking, and sodium chloride injection infusion smoothly, without any exception, during intravenous infusion is about 20 ml needle on one-piece rubber cap off, causing the situation of the patients, blood leakage of liquids immediately adopt measures to pull out the needle and oppression hemostasis, comfort to the patients.

Manufacturer Narrative

H.6.Investigation summary bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A device history review was conducted for lot number 7290347.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating leakage.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• 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: 9453363
• MDR Text Key: 180616120
• Report Number: 3006948883-2019-01066
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/21/2020
• Device Catalogue Number: 383406
• Device Lot Number: 7290347
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other