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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 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned for evaluation.
 
Event Description
It was reported "patient was being heparin locked to de-access today.Side port was cracked and leaking.Verge to follow.This was on the clear disc type port needle again.To be specific it is leaking just below where the syringe attaches, ie the tubing is split open and when it is flushed, the saline comes spurting out.".
 
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 damaged infusion set was confirmed.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 a needleless injection cap was attached to the luer adapter.A partially circumferential split was observed at the proximal luer/tubing joint.Microscopic inspection of the split revealed a granular fracture surface.Beach marks were observed throughout the fracture surface.Material buckling and discoloration were observed in the vicinity of the split.The split characteristics and material buckling were consistent with material failure due to repetitive stress.It appeared that the tubing fractured, in part, due to repetitive torsional (twisting) stress, suggesting that securement, access and maintenance techniques may have contributed; however, it appeared that an additional unidentified factor(s) may have contributed.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported "patient was being heparin locked to de-access today.Side port was cracked and leaking.Verge to follow.This was on the clear disc type port needle again.To be specific it is leaking just below where the syringe attaches, ie the tubing is split open and when it is flushed, the saline comes spurting out.".
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 19G 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
MDR Report Key11124806
MDR Text Key226778266
Report Number3006260740-2020-21192
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741066252
UDI-Public(01)00801741066252
Combination Product (y/n)N
PMA/PMN Number
K040527
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
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-0033YN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Date Manufacturer Received02/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age3 YR
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