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 Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7327621; medical device expiration date: 2021-11-30; device manufacture date: 2017-12-01.Medical device lot #: 6060981; medical device expiration date: 2020-03-31; device manufacture date: 2016-03-12.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 bd saf-t-intima¿ integrated safety catheter system leaked and the needle pierced through the catheter.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 7327621.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally our quality engineers have reviewed the samples submitted, and during leakage testing they determined that the only leaks present in the device were found at the puncture points in the catheter tubing.In response to the damaged catheter our engineers conducted a review of the manufacturing process but were unable to identify any opportunities to generate this failure mode in our manufacturing process.The root cause for this complaint could not be determined at the conclusion of our review.The reported leakage and needle through catheter were confirmed in both samples after to be inspecting.Based on investigation results to date, the root cause cannot be determined; however, by the conditions of the defect a possible cause could be the incorrect use from product.

Event Description

It was reported that the bd saf-t-intima¿ integrated safety catheter system leaked and the needle pierced through the catheter.

• 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: 8204629
• MDR Text Key: 131784157
• Report Number: 9610847-2018-00444
• 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: 01/24/2019

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: 383312
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other