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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asfvf112 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the y site of needle has crack.Patient status/ intervention: change new needle.
 
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, 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 a cracked infusion set y-site was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion with y-site.Usage residues were observed throughout the sample and the safety mechanism was engaged.Multiple cracks were observed in the white portion of the y-site valve housing.Microscopic inspection of the y-site confirmed multiple cracks in the white portion of the housing.Discoloration was observed in the vicinity of the cracks.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, during pressurization, a leaks were observed at the cracks in the y-site housing.Y-site damage, resulting in device leakage, was observed during evaluation.The discoloration accompanying the cracks suggested that an unidentified environmental factor(s) may have contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported that the y site of needle has crack.Patient status/ intervention: change new needle.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
kelsey erickson
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key14250362
MDR Text Key290443392
Report Number3006260740-2022-01557
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741066214
UDI-Public(01)00801741066214
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberLH-0031YN
Device Lot NumberASFVF112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2022
Initial Date FDA Received04/29/2022
Supplement Dates Manufacturer Received07/22/2022
Supplement Dates FDA Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2021
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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