MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.

Event Description

It was reported that patient was there for port flush and lab draw.Rn accessed the port with the safe step huber needle.Port accessing was successful.When rn was trying to de access port needle, rn grasped the needle with her dominant hand and stabilized the port needle with her thumb and forefinger.The needle did not pull up smoothly and it had resistance.The safety mechanism did not activate automatically, and the rn had difficulty retracting the cannula.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported that patient was there for port flush and lab draw.Rn accessed the port with the safe step huber needle.Port accessing was successful.When rn was trying to de access port needle, rn grasped the needle with her dominant hand and stabilized the port needle with her thumb and forefinger.The needle did not pull up smoothly and it had resistance.The safety mechanism did not activate automatically, and the rn had difficulty retracting the cannula.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.Additional information provided 12/19/2023: no urgent situations, only a delay of patient treatment (discharge).Patient was here for port flush and lab draw.Port accessing was successful.When rn was trying to de access port needle, rn grasped the needle wing with her dominant hand and stabilized the port needle base with her thumb and forefinger.The needle did not pull up smoothly and it had resistance.The safety mechanism did not activate automatically, and the rn had difficulty retracting the cannula.

Event Description

It was reported that needle did not pull up smoothly and it had resistance.The safety mechanism did not activate automatically, and the rn had difficulty retracting the cannula.Customer mentioned other incidents similar in the past, but dates are unknown.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.Additional information provided 12/19/2023 : no urgent situations, only a delay of patient treatment (discharge).Patient was here for port flush and lab draw.Port accessing was successful.When rn was trying to de access port needle, rn grasped the needle wing with her dominant hand and stabilized the port needle base with her thumb and forefinger.The needle did not pull up smoothly and it had resistance.The safety mechanism did not activate automatically, and the rn had difficulty retracting the cannula.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18319089
• MDR Text Key: 330466844
• Report Number: 3006260740-2023-05695
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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-0031
• Device Lot Number: ASGXFC086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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
• Patient Outcome(s): Other