MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383322

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/29/2019

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.

Event Description

It was reported that bd saf-t-intima¿ closed iv catheter system leaked blood.The following information was provided by the initial reporter: it was found blood leakage at tubing and blood luer connector.

Manufacturer Narrative

H.6.Investigation: bd was able to verify the reported issue of leakage by analyzing the provided picture.All samples are tested for leakage and they met acceptance criteria for the reported lot.The leak could be verified but the main cause could not be determined since the damage that caused the leak could not be observed and no sample was returned.Based on dhr review for material 383322 with lot number 8187503, all samples taken by qa tech during the manufacturing of product lot reported were tested against leakage and they properly met the acceptance criterial.

Event Description

It was reported that bd saf-t-intima¿ closed iv catheter system leaked blood.The following information was provided by the initial reporter: it was found blood leakage at tubing and blood luer connector.

• Brand Name: BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM
• 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: 8611801
• MDR Text Key: 145228296
• Report Number: 9610847-2019-00372
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833222
• UDI-Public: 30382903833222
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 383322
• Device Lot Number: 8187503
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other