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

Catalog Number 383336

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 03/08/2018

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.

Event Description

It was reported with the use of the bd saf-t-intima¿ iv catheter safety system there was an issue with safety mechanism failure.It was stated ¿after venipuncture with the bd saf-t-intima catheter when the healthcare working went to remove the needle, the needle was not caught in the safety device and the needle did not leave without the safety device.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Additional information: the customer sent an email adding the following detail to the complaint.No sample sent so the results reported in the supplemental mdr (b)(4), mfr.Report # 9610847-2018-00128 did not change.The needle has come out completely from the device, so the safety mechanism did not work properly.There was no damage.The professionals were focused and wearing ppe (personal protective equipment).((b)(6) 2018).

Manufacturer Narrative

H.6.Investigation results: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Without defective sample or photo for evaluation, we could not confirm or associate to manufacturing process.Quality records have been consulted and no issues like this are detected which means low occurrence.Product is functional tested as part of the manufacturing process and no incidents with safety shield activation failure or exposed cannula have been reported.A possible cause could be an incorrect use of the device by user.No definitive root cause could be determined.No capa was opened since this issue could not be confirmed as manufacturing related.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.

• 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
• MDR Report Key: 7495800
• MDR Text Key: 107991424
• Report Number: 9610847-2018-00128
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833369
• UDI-Public: 30382903833369
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2018

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: 10/31/2020
• Device Catalogue Number: 383336
• Device Lot Number: 6302612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 04/24/2018; 04/24/2018
• Supplement Dates FDA Received: 05/14/2018; 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other