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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 02/17/2022
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of a rough wire was confirmed but the cause is unknown. A series of photographs were returned for evaluation of this complaint. The photographs contained the distal end of the microintroducer/dilator/sheath and the proximal end of the guidewire. The proximal end of the guidewire appeared damaged, with the outer diameter of the wire appearing larger than the rest of the visible length 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. In addition to the damage seen on the guidewire, the distal end of the dilator appeared damaged. The orifice of the dilator was bent slightly out-of-round with the material flared outward. The dilator material contained light-colored discoloration in the damaged region. The increase in the effective outer diameter of the wire would have prevented the passage of a microintroducer over the wire and likely caused the damage seen on the dilator. 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 displacing the coils. 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)(6).
 
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. (b)(6) 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 first device.
 
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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 Key14247240
MDR Text Key290372160
Report Number3006260740-2022-01550
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 10/10/2022
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
Date Returned to Manufacturer02/22/2022
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
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