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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, CATHETER

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C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH 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 02/20/2022
Event Type  malfunction  
Event Description
It was reported that a little bit resistance was felt when the introducer guide wire was inserted into the introducer needle. But, the guide wire could not get through the needle tip nor get removed. The needle was immediately removed together with the guide wire. During operation, a new kit of seldinger from the same batch was opened and the introducer guide wire crossed through the introducer needle successfully. Puncture was made successfully with the new needle and new guide wire. After operation, the first needle was separated from the first guide wire carefully. Burrs were found at the proximal end of the guide wire. (b)(6) 2022 - deformation and misalignment of the coil wire was noted on the returned guidewire.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling. Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed but the exact cause remains unknown. Two photo samples of a guidewire were provided for evaluation. The first image shows the proximal end of the guidewire. Deformation and misalignment of the coil wire was noted. The surface characteristics of the damaged region could not be closely inspected. The deformation present on the guidewire is a likely contributing factor to the difficult advancement through the needle. The second image shows the product packaging label which indicates lot: reft0789. Based on the information provided, possible contributing factors include damage during handling or use. A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event. Since damage on the guidewire was observed in the images provided, the complaint is confirmed but the exact cause of the damage remains unknown. A lot history review (lhr) of reft0789 showed no other similar product complaint(s) from this lot number.
 
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Brand NameUNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH
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 Key14382463
MDR Text Key291599145
Report Number3006260740-2022-01737
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
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
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 NumberREFT0789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2022
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: 05/12/2022 Patient Sequence Number: 1
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