MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 5F DL POWERMIDLINE MAX KIT; MIDLINE CATHETER

Model Number N/A

Device Problems Material Deformation (2976); Difficult or Delayed Separation (4044)

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

Event Date 12/13/2023

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.H3 other text : device not returned.

Event Description

It was reported by the customer that picc kit had difficulty tearing and separating.Having to manipulate picc site leading to increased touches and risk for infection.Inability to place line is possible.

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 is pending evaluation.Results are expected soon.

Event Description

It was reported by the customer that picc kit had difficulty tearing and separating.Having to manipulate picc site leading to increased touches and risk for infection.Inability to place line is possible.

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 difficulty separating the microintroducer is confirmed; however, the root cause could not be determined.One photograph of a microintroducer was returned for evaluation.An initial visual observation of the photograph showed an implanted catheter and microintroducer.The t-handle was broken and the peel-apart sheath had been peeled most of the way.It appeared the t-handle did not completely break as a small piece of plastic was observed on the catheter.Although it appeared the microintroducer t-handle did not break evenly in the submitted photograph, inspection of the photograph was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.

Event Description

It was reported by the customer that picc kit had difficulty tearing and separating.Having to manipulate picc site leading to increased touches and risk for infection.Inability to place line is possible.

• Brand Name: 5F DL POWERMIDLINE MAX KIT
• Type of Device: MIDLINE CATHETER
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18441132
• MDR Text Key: 331901140
• Report Number: 3006260740-2023-06006
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741129360
• UDI-Public: (01)00801741129360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162900
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• 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: P4255108D
• Device Lot Number: REHW2072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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