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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
Catalog Number 0668945
Device Problems Material Too Rigid or Stiff (1544); Failure to Advance (2524)
Patient Problem No Patient Involvement (2645)
Event Date 06/07/2018
Event Type  malfunction  
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 manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of rebw0774 showed six other similar product complaints from this lot number.
 
Event Description
It was reported that there were visible "rough edges" at the end of three guidewires upon their removal from their package. It was stated that each one failed to pass through the needle when attempting insertion. All three devices were unusable, there was no patient involvement. This file addresses the third of the three devices.
 
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 initial indicated the sample had been received for evaluation. No actual sample was received for the third event reported. A lot history review (lhr) of rebw0774 showed six other similar product complaints from this lot number. Device not returned for evaluation.
 
Event Description
It was reported that there were visible "rough edges" at the end of three guidewires upon their removal from their package. It was stated that each one failed to pass through the needle when attempting insertion. All three devices were unusable, there was no patient involvement. This file addresses the third of the three devices.
 
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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
tesha udy
605 n. 5600 w.
salt lake city, UT 84116
8015225819
MDR Report Key7652536
MDR Text Key112996413
Report Number3006260740-2018-01574
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00801741074530
UDI-Public(01)00801741074530
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K915167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0668945
Device Lot NumberREBW0774
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/28/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2017
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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