MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y18GAX1.16IN PRN/EC SLM; INTERVASCULAR CATHETER

Catalog Number 383005

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/22/2019

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 y18 ga x 1.16 in prn/ec slm experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the needle hub during penetration.For the patient line to enhance ct examination, to the middle of the elbow to the retention needle puncture, puncture found that the left-in-the needle core tail leakage, a small amount of blood dripping on the hands of the patient and medical staff, immediately remove the needle core, and the patient's hands to wipe the blood clean.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8080269.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.Although a sample could not be provided, from previous investigations we know, that as the septum ages, the septum will lose elasticity.Experimental testing of septums in hot of dry environments determined that the septum will age, losing its elasticity and ultimately failing to successfully close after cannula removal.In response to this event we have notified our contracted shipping companies, and recommunicated bd's expectations for the implementation of environmental controls, during shipment and storage of our devices.

Event Description

It was reported that the intima-ii y18gax1.16in prn/ec slm experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the needle hub during penetration for the patient line to enhance ct examination, to the middle of the elbow to the retention needle puncture, puncture found that the left-in-the needle core tail leakage, a small amount of blood dripping on the hands of the patient and medical staff, immediately remove the needle core, and the patient's hands to wipe the blood clean.

• Brand Name: INTIMA-II Y18GAX1.16IN PRN/EC SLM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 8899528
• MDR Text Key: 155975235
• Report Number: 3006948883-2019-00659
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383005
• Device Lot Number: 8080269
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other