MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM; CATHETER

Catalog Number 383012

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Blood Loss (2597)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that intima-ii y 20 ga x 1.16 in prn/ec slm leaked at the catheter junction.This was discovered during use.The following information was provided by the initial reporter: the connection between the needle and the indwelling needle was broken, and the patient suffered slight bleeding.A new indwelling needle was replaced after treatment.

Manufacturer Narrative

H.6.Investigation summary a device history review was conducted for lot number 9239029.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot.The units were performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.See h.10.

Event Description

It was reported that intima-ii y 20gax1.16in prn/ec slm leaked at the catheter junction.This was discovered during use.The following information was provided by the initial reporter: the connection between the needle and the indwelling needle was broken, and the patient suffered slight bleeding.A new indwelling needle was replaced after treatment.

• Brand Name: INTIMA-II Y 20GAX1.16IN PRN/EC SLM
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10131123
• MDR Text Key: 204748039
• Report Number: 3006948883-2020-00222
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/23/2022
• Device Catalogue Number: 383012
• Device Lot Number: 9239029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other