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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFETY HUBER 20G X 0.75IN WITH NF VALVE SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS SAFETY HUBER 20G X 0.75IN WITH NF VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 585112
Device Problem Partial Blockage (1065)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 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 bleedback through the infusion set was inconclusive due to the sample condition. One photograph was provided for investigation. The photo showed one 20g ez huber infusion set being used on a patient. A dressing was attached to the needle housing. The extension set tubing between the needle housing and the y-site, and between the y-site and the proximal clamp was full of what appeared to be blood. The distal clamp appeared to be closed. The proximal clamp was not fully shown in the photo. The proximal end of the proximal clamp, the luer adaptor, and connection made at the luer adaptor were not visible in the photo. Although blood was visible in the extension set tubing, the cause of and the conditions surrounding the reported event were unknown. Potential contributing factors include the pressure gradient within the infusion set, improper connections, and clamp damage. The product ifu states, ¿fully tighten all connections, y-site end caps, or needleless connectors before use. Failure to attach an end cap or appropriate needleless device after removing a male luer locking end cap or needleless connector can result in an embolism or bleeding". A lot history review (lhr) of recn2786 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that port was accessed without difficulty, but blood backed up the length of the tubing. It was stated patient was receiving iv flush infusion at the time.
 
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Brand NameSAFETY HUBER 20G X 0.75IN WITH NF VALVE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7539200
MDR Text Key109251335
Report Number3006260740-2018-01064
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation
Type of Report Initial
Report Date 05/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number585112
Device Lot NumberRECN2786
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
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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