MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN.; INTERVASCULAR CATHETER

Catalog Number 383313

Device Problems Break (1069); Defective Device (2588)

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

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd saf-t-intima iv catheter safety system 24 g x 0.75 in.Experienced defective tubing/damage.The customer reported, "on the second day of placement, the extension tube was found broken when unclamping for transfusion.".

Manufacturer Narrative

Investigation: a device history report was conducted for lot number 8057575.Our records show that this is the second instance of this issue occurring in this production batch according to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Additionally the device that was returned to us by your facility, was subjected to leakage testing; the leakage that was observed, was seen flowing out of a small cut in the extension tubing.Our engineers attempted to duplicate this event by testing the interaction between the extension tubing and the connected pinch clamp.After ten iterations of this testing our engineers were unable to duplicate the reported failure mode.The reported defect defective could not be associated to our assembly process.The only way to reproduce this defect is omitting the ifu usage recommendations.Unfortunately based on our results, the root cause for this complaint could not be determined at the conclusion of our review.

Event Description

It was reported that the bd saf-t-intima iv catheter safety system 24 g x 0.75 in.Experienced defective tubing/damage.The customer reported, "on the second day of placement, the extension tube was found broken when unclamping for transfusion.".

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN.
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8434307
• MDR Text Key: 139305101
• Report Number: 9610847-2019-00233
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383313
• Device Lot Number: 737622
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other