MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERLOC INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 06/04/2023

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 device has not been returned to the manufacturer for evaluation.

Event Description

It was reported via medwatch "soft tubing just before the proximal port (just before where soft tubing connects to hard plastic) found to have completely separated (now in 2 pieces).Patient was at home, needle in for intermittent iv antibiotics, and nothing was infusing at this time.This opened up central line to infection, necessitated needle removal, and an ed visit for reinsertion (painful in child)." additional information from customer response (b)(6) 2023: patient has aplastic anemia.The event did not involve an urgent or life threatening medical situation.The event was discovered by the patient' s mother.The patient had to go to the outpatient clinic for an "additional clinic", additional needle insertion, and increased risk for infection.The patient did not have any symptoms and there was no harm or negative outcome for the patient.

• Brand Name: BARD POWERLOC INFUSION SET
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17313093
• MDR Text Key: 319123995
• Report Number: 3006260740-2023-02913
• 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: Other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 16 MO