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 Hole In Material (1293)

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

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).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 during use of the bd saf-t-intima¿ integrated safety catheter system when nurse was using the device and placed the iv she found a small hole in the tubing.No exposure to mucous membranes.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: bd received samples from the customer facility for investigation.The sample was evaluated under magnification using macro uv equipment and the customer's indicated failure mode for tubing defective with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: the potential root cause to the damage can be related with the assembly of the product in final assembly since this device is made 100 manual.This defect could be related with an incorrect assembly of cannula in the catheter in final assembly.

• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7123263
• MDR Text Key: 95078303
• Report Number: 9610847-2017-00182
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: 30382903833123
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 383312
• Device Lot Number: 6286667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other