MAUDE Adverse Event Report: AMSINO MEDICAL (SHANGHAI) CO. ABBOCATH-T 20G 1-1/4IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 0G7179790

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

Patient Problems Bacterial Infection (1735); Erythema (1840); Pain (1994)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

It was reported that a abbocath-t, 20 gauge x 1 ¼ inches with iso color coding, was reported to have caused redness and pain at the access point of the implanted device.The following issue was reported by the customer, device implanted on (b)(6) 2024.First use.The patient presents redness and pain at the access point of the needle cannula, and a fever of 38.Consequences: prolonged hospitalization.The status of the product at the time of the event is unknown.There was no delay in critical therapy, the medical intervention was needed, antibiotic therapy was implemented, an ointment was applied, and cryotherapy was performed.The patient's clinical condition before the event was stable and subsequently worsened.There was no serious injury.The drug used was ceftazidime 1g.The device has been replaced and therapy completed.No additional information is available at this time.

• Brand Name: ABBOCATH-T 20G 1-1/4IN
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): AMSINO MEDICAL (SHANGHAI) CO.; no 1-3, 16, ln 355, huazhe rd; shanghai 20161 3; CH 201613
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19126812
• MDR Text Key: 340449211
• Report Number: 3005515211-2024-00001
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10887709100661
• UDI-Public: (01)10887709100661(17)280821(10)56-208-KY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0G7179790
• Device Lot Number: 56-208-KY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/17/2024
• 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
• Treatment: CEFTAZIDIME 1G, UNK MFR
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female