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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 INTRO 4.5F X 5CM INTRODUCER, CATHETER

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C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRO 4.5F X 5CM 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 03/24/2022
Event Type  malfunction  
Manufacturer Narrative
The information provided by bd 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 bd. The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of the introducer needle cover falling off was confirmed; however, the root cause was not identified. The product returned for evaluation was one photograph which depicted a 4. 5fr microez microintroducer kit. The photograph depicted the product label. Several kit components were visible beneath the label. A portion of the 21ga introducer needle, including the luer adapter and part of the needle shaft, was visible. The plastic needle cover was not visible covering the needle shaft. The visible portion of the needle shaft was uncovered in the submitted photograph; however, inspection of the photograph was insufficient to determine precisely when/how the needle cover was removed. Consequently this complaint is confirmed as ¿cause unknown¿ at this time. Potential contributing factors include device manipulation during handling/storage. A lot history review (lhr) of redy1786 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that when preparing for the puncture in this patient, the nurse opened the seldinger kit and found that the introducer needle cover inside fell off. On (b)(6) 2022 - the plastic needle cover was not visible covering the needle shaft in the returned sample.
 
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Brand NameUNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRO 4.5F X 5CM
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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key14465273
MDR Text Key292364141
Report Number3006260740-2022-01911
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 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2022
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 NumberREDY1786
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
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: 05/21/2022 Patient Sequence Number: 1
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