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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 7 FR. PTFE INTRO KIT PORT AND CATHETER ACCESSORIES

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BARD ACCESS SYSTEMS 7 FR. PTFE INTRO KIT PORT AND CATHETER ACCESSORIES Back to Search Results
Model Number 0601170
Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Patient Problem Pneumothorax (2012)
Event Date 12/09/2019
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. (expiration date: 07/2023).
 
Event Description
It was reported that during port device implant, the introducer needle allegedly broke in the patient. It was further reported that imaging allegedly identified pneumothorax. Reportedly, the broken part of the needle was removed and intervention was required to remove the port device. The patient was reported as stable.
 
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Brand Name7 FR. PTFE INTRO KIT
Type of DevicePORT AND CATHETER ACCESSORIES
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX 88780
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9554252
MDR Text Key174528364
Report Number3006260740-2019-04072
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K860432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0601170
Device Catalogue Number0601170
Device Lot NumberREDU0409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated by Manufacturer? Yes
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: 01/06/2020 Patient Sequence Number: 1
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