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

Model Number N/A

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2019

Event Type  malfunction  

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 difficulty engaging the safety mechanism 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 approximately midway along the needle shaft.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 resistance was encountered when attempting to advance the safety mechanism metal sleeve past the bent region of the needle shaft.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 ascys0162 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the safety needle did not retract, risk of needlestick injury to rn.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G 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: 8724318
• MDR Text Key: 149075224
• Report Number: 3006260740-2019-01746
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0029
• Device Lot Number: ASCYS0162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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