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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; INTERVASCULAR CATHETER
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383319
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced foreign matter in or on device cannula/needle/catheter.The following information was provided by the initial reporter: material no.: 383319 batch no.: 0171902 found a lint on needle before insertion.Needle discarded by denise.
 
Event Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced foreign matter in or on device cannula/needle/catheter.The following information was provided by the initial reporter: material no.: 383319 batch no.: 0171902 found a lint on needle before insertion.Needle discarded by denise.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 0171902.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.This is the first complaint for foreign matter on material 383319 & batch 0171902.See h.10.
 
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Brand Name
BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key11388462
MDR Text Key238665930
Report Number9610847-2021-00087
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
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 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383319
Device Lot Number0171902
Was Device Available for Evaluation? No
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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