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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM INTRODUCER, CATHETER

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BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problem No Patient Involvement (2645)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of redr0299 showed two other similar product complaint(s) from this lot number. The complaints for this lot number (redr0299) have been reported from the same facility in (b)(6).
 
Event Description
It was reported that when performing the procedure on (b)(6) 2020, an operator found that the guide wire rusted. It was not used on the patient.
 
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of redr0299 showed two other similar product complaint(s) from this lot number. The complaints for this lot number (redr0299) have been reported from the same facility in china.
 
Event Description
It was reported that when performing the procedure on (b)(6) 2020, an operator found that the scalpel for skin expansion and the guide wire rusted. It was not used on the patient.
 
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Brand NameUNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
Type of DeviceINTRODUCER, CATHETER
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 Key10264128
MDR Text Key198542915
Report Number3006260740-2020-02408
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00801741074530
UDI-Public(01)00801741074530
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K915167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberN/A
Device Catalogue Number0668945
Device Lot NumberREDR0299
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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