MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER

Catalog Number 0668945

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Numbness (2415); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redn4026 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(4).

Event Description

It was reported the patient was admitted to the hospital for more than 3 months due to progressive dysphagia and was diagnosed with esophageal cancer after undergoing relevant examinations.There were indications for chemotherapy and radiotherapy.The relevant examinations were improved.There was no contraindication to chemotherapy.The right deep vein catheter was placed on (b)(6) 2020, (b)(6) 2020, (b)(6) 2021, and (b)(6) 2021 received 3 courses of tp chemotherapy, and radiotherapy for esophageal cancer was started on (b)(6) 2021.The patient reported pain in the right upper limb and swelling of the distal limb on (b)(6) 2021.Numbness, which means perfecting the b-ultrasound examination of the right upper limb vein, which indicates that after deep vein catheterization of the right upper limb, thrombosis is treated with nadroparin calcium anticoagulation treatment.After treatment, the above symptoms have improved significantly, and the condition is still closely observed.And to dynamically review the blood vessel b-ultrasound to observe the thrombosis.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• Type of Device: INTRODUCER, 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11865902
• MDR Text Key: 252401166
• Report Number: 3006260740-2021-01946
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0668945
• Device Lot Number: REDN4026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• 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
• Patient Age: 64 YR