MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERLOC 20G X .75"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Misassembled (1398); Activation Problem (4042)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

It was reported by customer that safety mechanism pulled off and they could not cover the needle.The rn was deaccessing the patient so pulled the port needle out of the chest as she was doing this, the needle safety device completely fell off and onto the patient¿s lap.Therefore, the rn couldn¿t even pull the safety device over the needle since it literally fell off while she deaccessed.

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 manufacturer has received the sample and will evaluate.Results are expected soon.

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 complaint of safety mechanism detachment was confirmed and the cause was supplier-related.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion set with y-site.Usage residues were observed throughout the sample.The safety mechanism was fully detached from the assembly and was received loose.Microscopic inspection of the safety mechanism revealed that a metal sleeve was present within the plastic collar of the safety mechanism.The sleeve inner diameter was measured using a digital microscope and found to be 0.0432¿, which corresponds to a 19ga needle.The needle shaft outer diameter was measured using digital calipers and found to be 0.0355¿.A non-complainant metal sleeve inner diameter was measured and found to be 0.0371¿.The safety mechanism detachment was caused by the incorrect metal sleeve being included in the assembly.It appeared that the safety mechanism was assembled using a metal sleeve that corresponds to a 19ga needle.The device is a supplied component and the supplier has been notified of this event.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by customer that safety mechanism pulled off and they could not cover the needle.The rn was deaccessing the patient so pulled the port needle out of the chest as she was doing this, the needle safety device completely fell off and onto the patient¿s lap.Therefore, the rn couldn¿t even pull the safety device over the needle since it literally fell off while she deaccessed.

• Brand Name: BARD POWERLOC 20G X .75"
• 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17741275
• MDR Text Key: 324025041
• Report Number: 3006260740-2023-04076
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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