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 383336

Device Problem Fail-Safe Design Failure (1222)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 after performing venipuncture, the safety device on a bd saf-t-intima¿ iv catheter safety system would not activate when withdrawing the needle.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: without sample received to perform an investigation, we cannot confirm or associate the reported defect to manufacturing process.Two pictures received do not show the product or reported defect.This reported defect is not common in our process; however, a possible cause could be the use incorrect of this device after venipuncture.Investigation conclusion: we could not find the exact root cause of the issue.No sample or photo was returned for evaluation.

• 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: 7311577
• MDR Text Key: 101636515
• Report Number: 9610847-2018-00036
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: 00382903833368
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

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: 12/31/2020
• Device Catalogue Number: 383336
• Device Lot Number: 7004943
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other