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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG MID LINE MINI TRAY 4F (EXPORT ONLY) CATHETER, PERCUTANEOUS

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BARD ACCESS SYSTEMS GROSHONG MID LINE MINI TRAY 4F (EXPORT ONLY) CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number 7715435CE
Device Problems Crack (1135); Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative

The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.

 
Event Description

It was reported that the patient has monthly infusion therapy with prostanoids. On (b)(6) 2018 suction was attempted for blood sampling and infusion by the picc team without any success. It was stated, ¿ultrasound control of catheter placement in the vascular bed and given the malfunctioning in the suspect of cracking, in the first centimeters, withdrawal of the same up to a total length of 18 cm¿. Rx performed with confirmation of md the segment was present in the right pulmonary artery. Patient sent to interventional cardiology where, with the adra snare system, the catheter segment of approximately 19 cm was removed.

 
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Brand NameGROSHONG MID LINE MINI TRAY 4F (EXPORT ONLY)
Type of DeviceCATHETER, PERCUTANEOUS
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. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7498814
MDR Text Key107737790
Report Number3006260740-2018-00933
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK871080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 05/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7715435CE
Device LOT NumberREABS1543_INVALID
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
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: 05/09/2018 Patient Sequence Number: 1
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