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

Catalog Number 383405

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Results: investigation summary: samples were returned and decontaminated for investigation.All samples and photos returned by the customer are for an intima ii 18g.The batch is 7019422, and there is blood on the end of the septum of the sample.Since the returned sample is similar to that of the photograph, this report only chooses representative samples and photos.The sample and the photo showed the reported defect.The septum from complaint/failed samples was inspected under 10x microscope.Observed that the hole was not fully closed after the needle was removed.Leak test was performed on 220 unused samples from the affected lot that were returned by the customer.Found 4 of the 220 samples with leakage when subjected to system pressure of 45psi which failed specification.Ten retained samples from the affected batch #7019422 were tested for leakage test to 45psi system pressure per product specification.No leakage was observed in retained samples.The septums were also inspected under 10x microscope and no abnormality was found.The affected products were sent to 89 distributors and 52 hospitals.Only 5 out of the 89 distributors have reported leakage to date.The time for the complaint product to be sent to the complaint area by the distributor is in july/august (summer peak season).A review of the device history record revealed no irregularities during the manufacture of the reported lot #7019422.Investigation conclusion: the affected products could have only been subjected to a higher temperature than usual during the hot summer.The factory is fully investigating such defects.Thorough investigation followed by corrective and preventative actions will be conducted and implemented in capa (b)(4).Bd was able to duplicate or confirm the customer¿s indicated failure mode.The product was within specification.

Event Description

It was reported that a nurse found blood leaking from the needle hole of the septum on a bd intima-ii¿ closed iv catheter system after venipuncture.There was no report of injury or medical intervention.

• 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: 7140686
• MDR Text Key: 95831166
• Report Number: 3006948883-2017-00183
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143610
• 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
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 383405
• Device Lot Number: 7019422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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