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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 Problems Corroded (1131); Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2021
Event Type  malfunction  
Event Description
It was reported that before the package was opened, many black particles could be visible inside the package.It was stated this occurred with three devices.This report addresses the second device.
 
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recw1561 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (recw1561) have been reported from the same facility in (b)(6).
 
Event Description
It was reported that before the package was opened, many black particles could be visible inside the package.It was stated this occurred with three devices.This report addresses the second 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 lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of dark particles within a kit is confirmed; however, the exact cause is unknown.Three 4.5 fr x 5 cm microez microintroducer kits were returned for evaluation.An initial visual observation showed each kit was re.Turned sealed.A dark reddish-brown residue was observed within each kit and on the components within the kits, particularly on the blades of the scalpels and around the distal ends of the needles.While a dark reddish-brown residue was observed in the returned kits, it is unknown how this residue accumulated on the returned samples.Possible contributing factors include oxidation due to moisture contacting the kit components during transit or storage.Relevant manufacturing records were reviewed, and no evidence of manufacturing-related deviations or issues related to this product failure were found.H3 other text : evaluation findings are in section h.11.
 
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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 Key13253787
MDR Text Key283950419
Report Number3006260740-2022-00013
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 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
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 NumberRECW1561
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2018
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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