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 383312

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system needle was loose and affected the insertion.The following information was provided by the initial reporter, translated from (b)(6) to english: "when the indwelling needle was used to prepare the needle for the patient's intravenous infusion, it was found that the needle tip could not be fixed and moved up and down, affecting the needle insertion.The second inspection of the indwelling needle showed that the core of the indwelling needle was bent and could not be pulled out".

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system needle was loose and affected the insertion.The following information was provided by the initial reporter, translated from chinese to english: "when the indwelling needle was used to prepare the needle for the patient's intravenous infusion, it was found that the needle tip could not be fixed and moved up and down, affecting the needle insertion.The second inspection of the indwelling needle showed that the core of the indwelling needle was bent and could not be pulled out".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 8299697.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

• 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: 11068299
• MDR Text Key: 227048017
• Report Number: 9610847-2020-00426
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: 30382903833123
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 383312
• Device Catalogue Number: 383312
• Device Lot Number: 8299697
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1