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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 383319
Device Problem Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/11/2021
Event Type  Injury  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #:0233518, medical device expiration date: 2024-08-31, device manufacture date: 2020-09-23, medical device lot #: 0266560, medical device expiration date: 2024-08-31, device manufacture date: 2020-10-07. 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 when using the bd saf-t-intima¿ iv catheter safety system, the device experienced prn separated from the adapter. The following information was provided by the initial reporter. The customer stated: it is really "poor" as it stands: the mds concerned are not kept, the batch number is not recorded, it is difficult to attribute a mds because 2 differents medical devices from 2 different suppliers are involved and we will never know whether it was a screw thread defect or a human error when screwing in. Bleeding in a newborn aged 1 month 12 days. Haemoglobin 6. 5 g/l requiring a transfusion. Additional information received i- 23rd sept. In neonatology, a 1 month and 12 day old baby hospitalised for pyelonephritis, for which a central venous line had been installed for treatment, was found at 9am on (b)(6) 2021 with a large bloodstain in his sleeping bag, mainly at the level of the sampling site. The cap of the central venous line fallen into the sleeping bag and the bleeding was stopped by coagulation in the peripheral venous line.
 
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Brand NameBD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of DeviceINTRAVASCULAR 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 Key12638328
MDR Text Key276578606
Report Number9610847-2021-00501
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383319
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/15/2021 Patient Sequence Number: 1
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