MAUDE Adverse Event Report: AMSINO MEDICAL (SHANGHAI) CO., LTD. SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM; STOPCOCK, I.V. SET

Catalog Number 32.828C

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A sample was received for evaluation.The investigation is pending.

Event Description

The customer reported a gravity administration set, vented with clave that the roller clamps were too loose to be held at the middle position and some positions where they preferred for the drip rate.The clamps would disposition back to the unclamped status, which affects their practice of applying the iv set on the patients as they always set the drip rate say q6, q8, and they would come back 6hrs or 8hrs later for checking.Due to the loose roller clamp, the saline to be dripped for the patient ran empty earlier, 2-3 hours before they come back for checking.The patient was connected with an empty ns bottle/bag for 2-3 hours, but no harm and no medical intervention were reported.This report captures the first of five events.

Manufacturer Narrative

H11: subsequent to the initial submission, it was found that list number 32.828c, or similar device, is not marketed in the u.S.By icu medical, inc., therefore not covered by k964435.Upon further review, it was determined that the medical device report was inadvertently submitted.

• Brand Name: SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): AMSINO MEDICAL (SHANGHAI) CO., LTD.; see h10; shanghai 20161 3; CH 201613
• MDR Report Key: 10539452
• MDR Text Key: 213043895
• Report Number: 3005515211-2020-00001
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32.828C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE, UNK MFR