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

Catalog Number 383312

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 12/07/2018

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 that the extension tubing of the bd saf-t-intima¿ integrated safety catheter system was broken and it caused leakage.

Manufacturer Narrative

Investigation summary: a device history report was conducted for lot number 7327591.During our review no abnormalities related to this event were found during our monitoring of the manufacturing process.According to our records lot was manufactured december 3, 2017, and this is the only instance of a defective catheter occurring in this lot.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 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 thirty iterations of this testing our engineers were unable to duplicate the reported failure mode.Unfortunately based on our results, the root cause for this complaint could not be determined at the conclusion of our review.Sample and slide clamp received were used to reproduce the reported defect.Pvc tubing was clamped 20 times without damages.Also, tubing was left 4 hours clamped and, no damage or cut was observed in the tubing, only stress mark.Slide clamp was reviewed and, no burr was observed.Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.These inspections are performed by operators and/or process control technicians to ensure any gross process.Process fmea 4797 and p-eura rm5942 were reviewed and there are proper controls in place to detect product malfunctions.

Event Description

It was reported that the extension tubing of the bd saf-t-intima¿ integrated safety catheter system was broken and it caused leakage.

• Brand Name: BD SAF-T-INTIMA¿ INTEGRATED SAFETY 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: 8206685
• MDR Text Key: 131767059
• Report Number: 9610847-2018-00443
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 383312
• Device Lot Number: 7327621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other