MAUDE Adverse Event Report: BD (SUZHOU) BD VACUTAINER K2E 10.8MG PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367864

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 06/12/2020

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.(b)(4).

Event Description

It was reported that the bd intima-ii closed iv catheter system indwelling needle was found leaking during infusion.The following information was provided by the initial reporter, translated from (b)(6) to english: device was placed on the back of the left hand of patient.Normal infusion was conducted and routine catheter maintenance was conducted.On the next day, at around 8:30 am of the shift, blood was oozing from the puncture site.There was no high-pressure injection during the indwelling period, and the indwelling period was 2 days.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system indwelling needle was found leaking during infusion.The following information was provided by the initial reporter, translated from chinese to english: device was placed on the back of the left hand of patient.Normal infusion was conducted and routine catheter maintenance was conducted.On the next day, at around 8:30 am of the shift, blood was oozing from the puncture site.There was no high-pressure injection during the indwelling period, and the indwelling period was 2 days.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 9170850.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 our investigation preventing our engineers form determining a root cause; leakage at the inserter can be related to the angle of insertion or the application of medical dressing.The bd intima-ii should be inserted into the patient at an angle of approximately 15 - 30 degrees.

• Brand Name: BD VACUTAINER K2E 10.8MG PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10271307
• MDR Text Key: 201548124
• Report Number: 3006948883-2020-00290
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/07/2022
• Device Catalogue Number: 367864
• Device Lot Number: 9170850
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 MO