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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 Problem Cellulitis (1768)
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.Multiple lot numbers: 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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd saf-t-intima¿ iv catheter safety system was used and the customer had an infection.This was discovered during use.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.
 
Manufacturer Narrative
Investigation summary: a device history review was conducted for lot numbers 8290668 & 8334770.Our records show that this is the second 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.Bd will continue to monitor this issue and encourages you to submit your sample for review.
 
Event Description
It was reported that bd saf-t-intima¿ iv catheter safety system was used and the customer had an infection.This was discovered during use.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.
 
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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 Key9310009
MDR Text Key169075289
Report Number9610847-2019-00674
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383328
Device Lot NumberSEE H.10
Initial Date Manufacturer Received 10/28/2019
Initial Date FDA Received11/12/2019
Supplement Dates Manufacturer Received10/28/2019
Supplement Dates FDA Received12/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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