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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. SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I; INTRAVASCULAR CATHETER
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383313
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
Event Type  malfunction  
Manufacturer Narrative
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 saf-t-intima w/y adapter yel 24ga x.75i catheter was frayed.The following information was provided by the initial reporter: it was reported that the catheter was frayed.  verbatim: we have had several frayed 24 ga catheters and one frayed 22 ga catheter.
 
Manufacturer Narrative
H6: investigation summary bd received 1 sample submitted for evaluation.The reported issue was not confirmed upon inspection of the sample.Additional silicone from our manufacturing process was observed on the sample and could have been mistaken for product damage by the customer.The silicone is from our lubrication process that occurs at the final stages of production to assist in catheter insertion during application.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
 
Event Description
It was reported that saf-t-intima w/y adapter yel 24ga x.75i catheter was frayed.The following information was provided by the initial reporter: it was reported that the catheter was frayed.  verbatim: we have had several frayed 24 ga catheters and one frayed 22 ga catheter.
 
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Brand Name
SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
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 
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX  
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12601911
MDR Text Key277182484
Report Number9610847-2021-00493
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903833139
UDI-Public00382903833139
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383313
Device Lot Number0351253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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