MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MEDLINE; SAFETY BLOOD COLLECTION NEEDLE WITH HOLDER

Catalog Number	SBCH22G
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned samples of this event was requested but hasn't been received till now, no sample for evaluation.The dhr of this lot was reviewed without any similar issue, the retained samples were inspected and they all meet the specification.The event can't be confirmed, the root cause can't detected currently.No action will be taken currently; this issue will be monitored.A supplemental report will be submitted if further information received.
Event or Problem Description
(b)(6) hospital has noticed an issue with the most recent lot of products sbch21g and sbch22g.The rubber of the distal needle is not moving back into the correct place after the end user fills avacutainer tube with blood.This is causing the needle to remain exposed and leak blood onto the next vacutainer that the end user is trying to fill.This customer has not experienced this issue with the product since it converted in august, which makes it seem like it's a lot of issue.There have been 10 separate incidents among 10 different end users, including the phlebotomy supervisor.The customer would like to replace the inventory they have with inventory from a new lot number.

• Brand Name: MEDLINE
• Common Device Name: SAFETY BLOOD COLLECTION NEEDLE WITH HOLDER
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer (Section G): JIANGSU CAINA MEDICAL CO., LTD.; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer Contact: camel zhou ; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441-5 ; CH 214415
• MDR Report Key: 24127462
• Report Number: 3005670221-2026-00003
• Device Sequence Number: 13348261
• Product Code: JKA
• UDI-Device Identifier: 10197344039715
• UDI-Public: 0110197344039715
• Combination Product (Y/N): N
• PMA/510(K) Number: K200027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SBCH22G
• Device Lot Number: 241101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown