• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F INTRODUCER, CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of reft0763 showed one other similar product complaint(s) from this lot number. The complaints for this lot number have been reported from the same facility in (b)(4).
 
Event Description
It was reported that during catheter placement at picc clinic on (b)(6) 2022, after the guidewire was delivered and the introducer needle was removed, the distal end (non-double spiral tip) was found unsmooth and round humps were present so that the guide wire could not enter the micro-introducer. The device was replaced with another kit from the same batch, but the same problem occurred. This led to removal of the guidewire and re-puncture in the patient. On 04/12/2022 - one photo was returned to represent both devices used. The guidewire in the photo showed damage and the outer diameter of the wire appeared larger than the rest of the wire. The facility stated the same issue occurred with both devices. This report addresses the second device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key14241157
MDR Text Key290381152
Report Number3006260740-2022-01524
Device Sequence Number1
Product Code DYB
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 Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0668945
Device Lot NumberREFT0763
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2021
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: 04/28/2022 Patient Sequence Number: 1
-
-