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

Model Number 383313

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 prior to use it was discovered that the needle is loose with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter, translated from (b)(6) to english: at 9 o 'clock on (b)(6) 2019, it was found that needle core loosen before use , so a new indwelling needle was immediately replaced for backup, which did not cause any adverse reactions.

Event Description

It was reported that prior to use it was discovered that the needle is loose with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter, translated from chinese to english: at 9 o 'clock on (b)(6) 2019, it was found that needle core loosen before use, so a new indwelling needle was immediately replaced for backup, which did not cause any adverse reactions.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed by our quality engineer team for provided lot number 7293902.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported incident and all quality tests were found to be within specification.As a sample was not available for this incident, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be determined.There are current quality controls in place to detect this type of defect during the production process.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY 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 ; MX
• MDR Report Key: 9535290
• MDR Text Key: 192063602
• Report Number: 9610847-2019-00780
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 383313
• Device Catalogue Number: 383313
• Device Lot Number: 7293902
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other