MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0031

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 03/14/2018

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 asbus0036 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.

Event Description

It was reported leakage on the side of the needle base was found when air was discharged prior to use on patient.

Manufacturer Narrative

The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that the information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.Therefore this event is deemed not reportable per 21 cfr part 803 a lot history review (lhr) of asbus0036 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported leakage on the side of the needle base was found when air was discharged prior to use on patient.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
• Type of Device: SET, 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 Key: 7498700
• MDR Text Key: 107841730
• Report Number: 3006260740-2018-00917
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LH-0031
• Device Catalogue Number: LH-0031
• Device Lot Number: ASBUS0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1