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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 06/07/2022
Event Type  malfunction  
Event Description
It was reported that a protrusion was found at the distal end of the seldinger guidewire during insertion. This made it impossible for the introducer sheath to pass. The customer attempted to trim the guide wire with a scalpel, but failed. A new kit of seldinger was used and inserted. (b)(6) 2022 - during evaluation the returned device was found to be bent severely in several places.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed; however, the exact cause is unknown. One photograph of a guidewire was returned for evaluation. An initial visual observation of the photograph showed one end of the guidewire was bent severely in three or four places. The tip of the guidewire on this end could not be seen clearly in the returned photograph; however, it did appear to be somewhat damaged, but the weld tip appears to be present. The weld tip on the other end appeared to be present and intact. What appears to be usage residues were observed on the guidewire within the returned photograph. While the exact cause of the damage observed in the guidewire in the returned photograph is unknown, possible causes include damage during packaging, handling, or use. A lot history review (lhr) of reep1400 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 Key15165979
MDR Text Key301996444
Report Number3006260740-2022-03053
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 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
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 NumberREEP1400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2020
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: 08/04/2022 Patient Sequence Number: 1
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