MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 22 G X 0.75 IN.; INTERVASCULAR CATHETER

Catalog Number 383323

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd saf-t-intima iv catheter safety system 22 g x 0.75 in.Experienced leakage during use.The following information was provided by the customer: material no.383323, batch.Unknown (provided 8025673).It was reported the rubber stopper blew out of catheter and blood sprayed everywhere.We recently had a customer complain about product #383323.They said that the rubber stopper would blow out of the catheter, causing blood to spray out everywhere.The particular lot # is 8025673.They are returning their remaining case of that lot number to us.The initial reported from owens & minor called in a product complaint from one of their customers diagnostic x-ray and imaging.The affected product is 383323 lot 8025673.The end user stated the stopper blew out and sprayed blood.This was the 2nd incident they have had with this lot.They have 4 cases of the same lot.

Manufacturer Narrative

H.6.Investigation: 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.A dhr couldnot be performed as the lot# is unknown.

Event Description

It was reported that the bd saf-t-intima iv catheter safety system 22 g x 0.75 in.Experienced leakage during use.The following information was provided by the customer: material no.383323 batch.Unknown (provided 8025673) it was reported the rubber stopper blew out of catheter and blood sprayed everywhere.We recently had a customer complain about product #383323.They said that the rubber stopper would blow out of the catheter, causing blood to spray out everywhere.The particular lot # is 8025673.They are returning their remaining case of that lot number to us.The initial reported from owens & minor called in a product complaint from one of their customers diagnostic x-ray and imaging.The affected product is 383323 lot 8025673.The end user stated the stopper blew out and sprayed blood.This was the 2nd incident they have had with this lot.They have 4 cases of the same lot.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 22 G X 0.75 IN.
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8465238
• MDR Text Key: 141064443
• Report Number: 9610847-2019-00253
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: 00382903833238
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

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: 383323
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68