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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 4.5F; INTRODUCER, CATHETER
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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 03/03/2022
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reft4492 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reft4492) have been reported from the same facility in (b)(6).
 
Event Description
It was reported that two cases of catheter placement were performed at oncology department of the hospital.The guidewire entered the blood vessel following successful puncture.When the guide wire was passing through the sheath from the end, a protrusion was found at the end of the guidewire, making the passage fail.Since it was impossible to conduct re-puncture, the guide wire had been cut off.Two cases of the same problem occurred.This report addresses the first device.
 
Manufacturer Narrative
H11: section a through f - 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, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty passing the microintroducer over the guidewire was confirmed but the cause is unknown.A returned photograph of a small segment of a guidewire was reviewed as part of this complaint.The end of the wire, which is believed to be the proximal end, appeared to have a slightly larger diameter than the rest of the wire.The exact nature of the damage could not be determined due to the clarity of the photograph.However, the damage appeared to most likely be attributed to misalignment of the guidewire coils.The increase in the effective outer diameter of the wire would have prevented the passage of a microintroducer over the wire.Although the damage to the wire could be confirmed, the exact root cause of the damage could not be determined.A review of the manufacturing records did not find any potentially related issues that were encountered during the manufacture and assembly of the implicated product lot.Potential contributing factors could include attempted insertion of the wire against resistance or manipulation of the wire causing displacement of the coils.
 
Event Description
It was reported that two cases of catheter placement were performed at oncology department of the hospital.The guidewire entered the blood vessel following successful puncture.When the guide wire was passing through the sheath from the end, a protrusion was found at the end of the guidewire, making the passage fail.Since it was impossible to conduct re-puncture, the guide wire had been cut off.Two cases of the same problem occurred.This report addresses the first device.
 
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Brand Name
UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F
Type of Device
INTRODUCER, 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
kelsey erickson
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key13892388
MDR Text Key287895280
Report Number3006260740-2022-00931
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 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0668945
Device Lot NumberREFT4492
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
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 Sequence Number1
Patient Outcome(s) Other;
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