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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 383346
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 10/04/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.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.Device manufacture date: unknown.
 
Event Description
Material no.: 383346, batch no.: unknown.It was reported that during use of the bd saf-t-intima¿ iv catheter safety system the catheter separated from the inserter leaving the wing and the catheter in the patient.The following information was provided by the initial reporter: bd saf-t-intima catheter ref 383346 18ga 1.00in, 1.3 25mm.Separated from the wing portion of the catheter, leaving the wing and catheter in the patient.Remainder of device was removed and iv replaced in patient with new catheter.
 
Event Description
Material no.: 383346.Batch no.: unknown.It was reported that during use of the bd saf-t-intima¿ iv catheter safety system the catheter separated from the inserter leaving the wing and the catheter in the patient.The following information was provided by the initial reporter: bd saf-t-intima catheter ref (b)(4) 18ga 1.00in, 1.3 25mm.Separated from the wing portion of the catheter, leaving the wing and catheter in the patient.Remainder of device was removed and iv replaced in patient with new catheter.
 
Manufacturer Narrative
Additional information: medical device lot #: 8178622.Medical device expiration date: 6/30/2022.Device manufacture date: (b)(6)2018.Investigation summary: a device history review was conducted for lot number 8178622.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.
 
Event Description
Material no.: 383346, batch no.: unknown.It was reported that during use of the bd saf-t-intima¿ iv catheter safety system the catheter separated from the inserter leaving the wing and the catheter in the patient.The following information was provided by the initial reporter:.
 
Manufacturer Narrative
H.6.Investigation: unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Based on their evaluation of the provided photograph, our engineers have determined that the most likely root cause for this event is a lack of adhesive applied to the tubing tip.H3 other text : see h.10.
 
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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 Key9246139
MDR Text Key191722291
Report Number9610847-2019-00645
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833468
UDI-Public30382903833468
Combination Product (y/n)N
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Catalogue Number383346
Device Lot Number8178622
Date Manufacturer Received10/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
Patient Weight89
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