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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383328
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Swelling (2091)
Event Date 10/28/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8290668; medical device expiration date: 2022-09-30; device manufacture date: 2018-11-30; medical device lot #: 8334770; medical device expiration date: 2022-11-30; device manufacture date: 2019-01-03; 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 patient sustained a "cellulite infection" after the bd saf-t-intima¿ iv catheter safety system was used on them.The symptoms included "redness, fever, and swelling in the insertion site", and treatment had to be stopped so antibiotics could be used to treat the infection.Lot #'s 8290668 and 8334770 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "cellulite infection after using sc saf-t-intima, involving redness, fever, and swelling in the insertion site, in one patient it appears on the same day and in two patients after 3-4 days.The patients needed antibiotics for treating the infection"."stop treatment and start antibiotics course".
 
Manufacturer Narrative
Investigation summary: a device history review was conducted for lot numbers 8290668 & 8334770.Our records show that this is the first instance of this issue occurring in either production batch.According to the sampling plan applied for product performance, these lots were accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported that the patient sustained a "cellulite infection" after the bd saf-t-intima¿ iv catheter safety system was used on them.The symptoms included "redness, fever, and swelling in the insertion site", and treatment had to be stopped so antibiotics could be used to treat the infection.Lot #'s 8290668 and 8334770 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "cellulite infection after using sc saf-t-intima, involving redness, fever, and swelling in the insertion site, in one patient it appears on the same day and in two patients after 3-4 days.The patients needed antibiotics for treating the infection." "stop treatment and start antibiotics course.".
 
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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
MX 
MDR Report Key9310167
MDR Text Key169075014
Report Number9610847-2019-00675
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383328
Device Lot NumberSEE SECTION H.10.
Date Manufacturer Received10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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