MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2023

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.H3 other text : device not returned.

Event Description

It was reported, there is a fracture at the base of the cannula/powermidline catheter.Treatment has been interrupted after couple of days.No other information was provided.

Event Description

It was reported, there is a fracture at the base of the cannula/powermidline catheter.Treatment has been interrupted after couple of days.No other information was provided.

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 a leaking catheter is confirmed and was determined to be caused by kinking of the catheter.One 4 fr s/l powermidline catheter was returned for evaluation.An initial visual observation showed use residues throughout the returned device, and the catheter terminated at the 12 cm depth marker.A microscopic observation revealed a partially circumferential split just distal of the molded joint.The fracture surface appeared granular at the split exit site, and whitening was observed around the fracture edges.Based on the observations of the returned powermidline catheter, the complaint of a leaking catheter was confirmed and is likely due to excessive kinking of the catheter.This can occur if the securement of the catheter causes a sharp kink, and over a period of time the catheter may fail opposite of the kink impression.A review of the manufacture quality and inspection records for the implicated product batch indicated no potentially related issues occurred during product manufacture, assembly, and packaging.Additionally, a review of the complaint history did not indicate a potential batch-specific product issue.The reported event has been documented and included in complaint trending and will continue to be monitored as part of ongoing quality efforts.\.

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)
• 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: 16898986
• MDR Text Key: 314898792
• Report Number: 3006260740-2023-01773
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: P6154118
• Device Lot Number: REGS4076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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