• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number LH-0030
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
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, at this time, to the manufacturer for evaluation. A lot history review (lhr) of asats0210 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported nurse accessed adult patient port at home for ordered blood draw. Port accessed without problems, initial flush, patency check o. K. After drawing blood, nurse administered 2 (10 ml) normal saline (pre-filled) flushes per protocol. First flush without incident. When reaching end of second normal saline flush (flush content left was approximately 1 ml), nurse noticed a ¿single small bubble of liquid¿ appeared at the area where the extension tubing connects with the insertion handle. The remaining saline (1 ml) was administered. Next, a 5 ml (100 u/ml) heparin lock (pre-filled syringe) was administered (prior to de-accessing the needle). When injecting the heparin lock, upon reaching the final 1 ml mark on the syringe ¿ again, a ¿single small bubble of liquid¿ appeared at the area where the extension tubing meets the needle insertion handle. The heparin lock was completed by the nurse (i. E. The final 1 ml of heparin was administered into the port).
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 bubbles in the extension tubing was confirmed and the cause appeared to be supplier-related. The product returned for evaluation was one 22ga x 1¿ safestep safety infusion set. The sample was received with the safety mechanism engaged and usage residues were evident throughout the sample. A needleless injection cap was attached to the luer adapter. An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration; however, during aspiration, bubbles were noted in the extension tubing. During hydraulic pressurization, a leak was observed emanating from the needle housing. Microscopic inspection of the sample using an ultraviolet light revealed voids in the adhesive coverage within the housing. The leak appeared to be caused by a fluid path resulting from incomplete adhesive coverage within the needle housing. Such incomplete coverage appeared to be caused by void introduction/formation during device assembly. The device is a supplied component and the supplier has been notified of this event. A lot history review (lhr) of asats0210 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported nurse accessed adult patient port at home for ordered blood draw. Port accessed without problems, initial flush, patency check o. K. After drawing blood, nurse administered 2 (10 ml) normal saline (pre-filled) flushes per protocol. First flush without incident. When reaching end of second normal saline flush (flush content left was approximately 1 ml), nurse noticed a ¿single small bubble of liquid¿ appeared at the area where the extension tubing connects with the insertion handle. The remaining saline (1 ml) was administered. Next, a 5 ml (100 u/ml) heparin lock (pre-filled syringe) was administered (prior to de-accessing the needle). When injecting the heparin lock, upon reaching the final 1 ml mark on the syringe ¿ again, a ¿single small bubble of liquid¿ appeared at the area where the extension tubing meets the needle insertion handle. The heparin lock was completed by the nurse (i. E. The final 1 ml of heparin was administered into the port).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSAFESTEP HUBER NEEDLE SET 22G 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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7604002
MDR Text Key111622083
Report Number3006260740-2018-01405
Device Sequence Number1
Product Code FPA
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLH-0030
Device Catalogue NumberLH-0030
Device Lot NumberASATS0210
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Home
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-