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 383319

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Skin Inflammation (2443)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.Initial reporter's phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported after placement of the bd saf-t-intima iv catheter safety system, on several occasions, ¿allergic reaction, abscess, infection¿ was noted.There was no report of any medical interventions.

Manufacturer Narrative

Investigation results: one representative unit was received for analysis.Our quality engineer visually inspected the returned unit and no physical or mechanical damage or foreign matter was observed.A review of the device history records was performed and revealed no irregularities during the manufacture of reported lot number 6243989.We were unable to determine a root cause for this event.Reported defect was not confirmed in representative sample; since, during the inspection of this sample we do not find foreign matter in the catheter tip or needle tip.Certificate of sterility for this reported lot number 6243989 was reviewed and all the units (b)(4) meet with acceptance criteria.We cannot confirm or associate this reported defect to manufacturing process.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: 7196777
• MDR Text Key: 97436742
• Report Number: 9610847-2017-00232
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 383319
• Device Lot Number: 6243989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• 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