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

Catalog Number 383322

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

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd saf-t-intima¿ integrated safety catheter system was damaged at the juncture of the paddle hub and the extension tube, which cause leakage.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: a device history report was conducted for lot number 8025668.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 february 6, 2018, 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; no leakage was observed under product specifications.Our engineers also 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.Based on our results, the root cause for this complaint could not be determined at the conclusion of our review.The reported tubing defective/damaged by customer was not confirmed after visual inspection and functional the sample provided.Based on the results obtained, the defect tubing defective; could not be identified or confirmed, and cause could not be determined.Sample was tested per leak at 20 psi of in and, 8 psi of out according qcge-011sp.No leakage was found.Although image received showed leakage, the actual unit involved in the reported complaint event, sample showed no tubing damaged or leakage.Currently, 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 changes are identified.If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan.

Event Description

It was reported that bd saf-t-intima¿ integrated safety catheter system was damaged at the juncture of the paddle hub and the extension tube, which cause leakage.No serious injury or medical intervention was reported.

• Brand Name: BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM
• 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: 8203617
• MDR Text Key: 131707390
• Report Number: 9610847-2018-00452
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833222
• UDI-Public: 30382903833222
• 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: 02/11/2019

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 Catalogue Number: 383322
• Device Lot Number: 8025668
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other