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

Catalog Number 383336

Device Problem Fail-Safe Design Failure (1222)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(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 that after venipuncture, the needle on a bd safe-t-intima¿ iv catheter safety system popped up through the e-tubing ¿close to the wing¿ stabbing the nurse¿s hand.It was reported that the patient¿s blood was not contagious.There was no report of medical intervention.

Manufacturer Narrative

Bd had not received samples, but two photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for needle through tubing resulting in needle stick with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.After evaluating two photographs, we cannot associate the reported defects to manufacturing process, because both defects could be related with an incorrect use of the product.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.The root cause is considered a misuse of the defect.

• Brand Name: BD SAF-T-INTIMA¿ CLOSED IV 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: 7102558
• MDR Text Key: 94348848
• Report Number: 9610847-2017-00180
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833369
• UDI-Public: 30382903833369
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013800
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• 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: 383336
• Device Lot Number: 6277686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• 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