MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 383323

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no.: 383323, batch no.: 8025673.It was reported that during use of the bd insyte¿ autoguard¿ bc shielded iv catheter the rubber stopper would blow out of the catheter, causing blood to spray out everywhere.The following information was provided by the initial reporter: we received a product complaint regarding product 383323.She indicated that ¿rubber stopper would blow out of the catheter, causing blood to spray out everywhere¿.She provided the lot number of 8025673¿ please note the lot number provided does not match the batch in the po; information provided: po# (b)(4); lot# 8025673; material 383323 / 1 box.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8025673.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.Additionally outengineers reviewed the samples submitted by your facility, they were unable to identify the reported issue.Leakage testing was performed on the devices in an attempt to replicate the event; all of the tests indicated that the device were working as expected according to product specifications.Unfortunately based on our observations, the root cause for this complaint could not be determined at the conclusion of our review.

Event Description

Material no.: 383323 batch no.: 8025673 it was reported that during use of the bd insyte¿ autoguard¿ bc shielded iv catheter the rubber stopper would blow out of the catheter, causing blood to spray out everywhere.The following information was provided by the initial reporter: we received a product complaint regarding product 383323.She indicated that ¿rubber stopper would blow out of the catheter, causing blood to spray out everywhere¿.She provided the lot number of 8025673¿ please note the lot number provided does not match the batch in the po; information provided: po# 27872 lot# 8025673 material 383323 / 1 box.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8551772
• MDR Text Key: 145945755
• Report Number: 9610847-2019-00332
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: 30382903833239
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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 Expiration Date: 01/31/2022
• Device Catalogue Number: 383323
• Device Lot Number: 8025673
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other