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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fail-Safe Problem (2936)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2019
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling. Based on a review of this information, the following was concluded: the complaint that the safety mechanism would not activate completely could not be confirmed from the two photographs that were provided for investigation. The first photo showed the unit label with part number lh-0029yn and lot #ascts0134. The second photo showed the safestep infusion set within the packaging. The label applied to the back of the packaging was obscuring much of the device. The reported damaged could not be discerned from the photographs. The complaint was inconclusive since the functionality of the device could not be determined without the physical sample. A lot history review (lhr) of ascts0134 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported the safety mechanism was not activated completely. No other information was provided.
 
Manufacturer Narrative
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 safety mechanism failure was confirmed and the cause was determined to be use related. The product returned for evaluation was a one 22ga x 0. 75" safestep safety infusion set. The returned product sample was evaluated and the needle was observed to be bent just distal of the non-engaged safety mechanism. The following observations were noted during the sample evaluation: ¿ usage residue was seen on the sample which proved that the product had experienced at least some use ¿ the needle tip was barbed suggesting contact between the needle and port base the safety mechanism was not engaged upon sample receipt. The safety was successfully engaged; however, significant resistance was encountered when passing the metal safety sleeve over the bent region of the needle. Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft. It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion. Additionally, avoid excessive manipulation once the needle is in the port. No potential damage related to the manufacturing process was noted on the complaint sample. A lot history review (lhr) of ascts0134 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported the safety mechanism was not activated completely. No other information was provided.
 
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Brand NameSAFESTEP HUBER NEEDLE SET 22G X 0.75IN WITH Y-SITE
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 Key8796227
MDR Text Key151285756
Report Number3006260740-2019-01967
Device Sequence Number1
Product Code FPA
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLH-0029YN
Device Lot NumberASCTS0134
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2018
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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