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

Model Number N/A

Device Problem Suction Problem (2170)

Patient Problems Pain (1994); Numbness (2415); Thrombosis/Thrombus (4440)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

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.A lot history review (lhr) of refy0199 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported " resistance to removal for venous return; no venous return possible.Post explantation 2 days of right arm pain, edema, redness, reduced mobility, numbness in fingers and right hand.Venous doppler showed thrombophlebitis, requires fragment injections of 3 months.".

• Brand Name: POWERMIDLINE 5F DL BASIC
• 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: 15473280
• MDR Text Key: 300560802
• Report Number: 3006260740-2022-03698
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741141010
• UDI-Public: (01)00801741141010
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: P4255118
• Device Lot Number: REFY0199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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): Required Intervention