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

Catalog Number 383323

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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¿ iv catheter safety system the angiocath when placed the nurse attempted to flush, a puncture along the tubing was noted.The angiocath was leaking and had to be removed.There was no further report of injury or medical intervention.

Manufacturer Narrative

Correction: fda notified: the initial reporter also notified the fda of this incident via mw# (b)(4).Device evaluation: results: bd did not receive any samples or photos from the customer in support of this complaint.Without defective sample or photo it is difficult to determinate the root of cause.(b)(4) shows the procedures used to assemble this product.A dhr was not reviewed, because the complaint reported was not assigned a lot number.Bd was not able to duplicate or confirm the customer's indicated failure mode.Conclusion: unable to determine the root cause as no samples or photos were returned for evaluation.No capa was opened since this issue could not be confirmed as manufacturing related.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY 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: 7155137
• MDR Text Key: 96124134
• Report Number: 9610847-2017-00219
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: 30382903833239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

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: Nurse
• Device Catalogue Number: 383323
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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