MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II 18GAX1.16IN PRN SLM; IV CATHETER

Catalog Number 383000

Device Problem Crack (1135)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/15/2019

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 the intima-ii 18gax1.16in prn slm experienced product damage.The following information was provided by the initial reporter: it was found there was a crack on the side of needle leading to bleed.

Event Description

It was reported that the intima-ii 18gax1.16in prn slm experienced product damage.The following information was provided by the initial reporter: it was found there was a crack on th side of needle leading to bleed.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8171128.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.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: INTIMA-II 18GAX1.16IN PRN SLM
• Type of Device: IV CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 8575457
• MDR Text Key: 143975015
• Report Number: 3006948883-2019-00333
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/24/2021
• Device Catalogue Number: 383000
• Device Lot Number: 8171128
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other