MAUDE Adverse Event Report: AMSINO MEDICAL (SHANGHAI) CO., LTD VENISYSTEMS¿ ABBOCATH¿-T 20G X 32MM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problems Fracture (1260); Dent in Material (2526)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 01/23/2022

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event was reported to have been discarded.Without the return of the sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

It was reported that a 20g 32mm abbocath, with an unknown list number and unknown lot number, was being used for arterial line monitoring in a 13-year-old child during complex surgery, on (b)(6) 2022.The patient was placed on continuous monitoring and at 01:10hrs, on (b)(6) 2022, it was noted that the invasive blood pressure trace was not present on the monitor.Troubleshooting techniques were attempted but it was not possible to either drawback blood with a syringe nor flush the line suggesting an occlusion.At this point, after consultation with the nurse in charge, the decision was made to remove the cannula at which point the cannula had dislodged and the hub with a short amount of tubing attached was evident alongside the patient in the bedspace.The insertion site was bleeding, pressure was immediately applied with good effect.It was then noted that the cannula sheath had fractured and in fact, a portion of tubing had been retained in the left radial artery.The child required an additional procedure under anesthetic to remove the retained tubing.The device was reported to have been changed out/replaced with no further problems encountered.The patient had two peripheral cannulae in the left hand and arm respectively and an abbocath - 20 gauge 32mm arterial line in the left distal radial artery.The arterial cannula site was inspected but there was no swelling, bleeding, or redness visible.The abbocath had been secured with a transparent occlusive dressing - no steristrips or sutures had been employed.On inspection, the cannula tubing was noted to be shorter than would be expected.Neurovascular observations were commenced and ultrasound and x-ray were performed which both confirmed that a portion of the abbocath sheath had been retained in the artery.On inspection of the retrieved abbocath segment, the abbocath sheath appears to have been kinked and to have fractured.No additional information is available at this time.

Manufacturer Narrative

The device involved in the event was reported to have been discarded.The manufacturer received pictures of the defective sample.During a review of the submitted photos, it was found that the casing fractured at both ends.The probable cause of the reported event was found to be that the sample casing was affected by external force and then the casing fracture occurred.The investigation states the event could be a result of an unsuccessful indwelling needle puncture.The needle tube was seen to be set back inside the casing, subsequently, piercing the steel casing.After use, too much force in the removal of the casing caused a fracture, resulting in the retention of foreign material in the body.Visual inspection and related performance test on retention samples of the same specification of the reported defective device, and no abnormalities were found.Manufacturer plastic tip procedure and lai-distance inspection procedure are 100% checked, and there will be no casing fracture and defective products that will be shipped to market.The directions for use indicate that if the first puncture fails, it is not recommended that the client use the same needle for a second puncture, replace it with a new indwelling needle.

• Brand Name: VENISYSTEMS¿ ABBOCATH¿-T 20G X 32MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): AMSINO MEDICAL (SHANGHAI) CO., LTD; blding1-3,16, ln355, huazhe rd; songjiang exp processing zone; shanghai 20161 3; CH 201613
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13900133
• MDR Text Key: 298206688
• Report Number: 3005515211-2022-00001
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K973107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• 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
• Patient Age: 13 YR