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

Model Number N/A

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported "(b)(6) 2022 patient arrived to chemo unit reporting that he noted leaking from the tubing of his mediport needle with 5fu elastomeric pump currently infusing (attached yesterday).Patient arrived with clamps closed and moist gauze wrapped around proximal port of mediport infusion set.Patient stated he noted leaking sometime in the morning and that his t-shirt had an area of wetness.Hairline crack noted in mediport infusion set where the clave screws onto the infusion set and a crack in the clave itself at the proximal port.Mediport needle removed and 5fu elastomeric pump disconnected from mediport infusion set.No precipitate noted on patient's skin, skin cleansed with soap and water.New mediport needle infusion set used and mediport re-accessed.Flushed easily, good blood return.Elastomeric pump reconnected.Clamps in open and locked position.Patient discharged.Return tomorrow as scheduled for disconnect.".

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 "10/12/2022 patient arrived to chemo unit reporting that he noted leaking from the tubing of his mediport needle with 5fu elastomeric pump currently infusing (attached yesterday).Patient arrived with clamps closed and moist gauze wrapped around proximal port of mediport infusion set.Patient stated he noted leaking sometime in the morning and that his t-shirt had an area of wetness.Hairline crack noted in mediport infusion set where the clave screws onto the infusion set and a crack in the clave itself at the proximal port.Mediport needle removed and 5fu elastomeric pump disconnected from mediport infusion set.No precipitate noted on patient's skin, skin cleansed with soap and water.New mediport needle infusion set used and mediport re-accessed.Flushed easily, good blood return.Elastomeric pump reconnected.Clamps in open and locked position.Patient discharged.Return tomorrow as scheduled for disconnect.".

• Brand Name: BARD POWERLOC MAX
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15775413
• MDR Text Key: 306908131
• Report Number: 3006260740-2022-04936
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/13/2023
• 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