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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number LH-0032
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2018
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard 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 bard. The device has not been returned to the manufacturer, at this time, for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the "microclave connector came off of patients safestep huber needle at home. " no patient injury reported.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of the connector coming off of the safestep infusion set was confirmed and the cause appears to be use related. The product returned for evaluation was a 20g x 1 safestep infusion set. The investigation findings are consistent with damage accumulated through gradual deformation due to continuous outward-radiating stress within the luer hub orifice, also known as material creep. Likely sources of the stress include slip-fit style male luer adapters such as those found on some i. V. Administration sets and syringes. The returned product sample was evaluated and the characteristics observed which supported this type of failure included: the luer hub orifice was found to be out of iso tolerance using a calibrated taper gauge. Lack of mechanical damage on the luer hub. Attachment of the device to non-complainant slip-fit adapters was firm; however, the tapers could be fully inserted into the luer hub orifice. Attachment of the device to non-complainant luer-lock adapters was unremarkable the evidence suggests that a tapered object was forcefully inserted into the luer hub orifice then left in place, resulting in gradual widening, or creep, of the luer hub material. This type of failure was replicated at bas using 5 iso compliant slip-fit adapters and 5 non-complainant infusion sets. A combination of use of slip-fit style adapters, the force with which those adapters were inserted, and the duration of insertion resulted in this type of slow luer hub deformation. Creep deformation takes place over days; however, the rate of deformation depends upon the force used to insert the taper. This type of damage may possibly be mitigated by reducing the insertion force and/or using luer-lock style adapters. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the "microclave connector came off of patients safestep huber needle at home. " no patient injury reported.
 
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Brand NameSAFESTEP HUBER NEEDLE SET 20G X 1 IN
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
tesha udy
605 n. 5600 w.
salt lake city, UT 84116
8015225819
MDR Report Key7563133
MDR Text Key109994792
Report Number3006260740-2018-01196
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741066221
UDI-Public(01)00801741066221
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLH-0032
Device Catalogue NumberLH-0032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Home
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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