MAUDE Adverse Event Report: ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. TKMD; PISTON SYRINGE

Model Number TKSLL-001

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Customer reported that on (b)(6) 2022, upon inspecting the syringes, mold and condensation were discovered inside the sealed, packaged syringes.

Manufacturer Narrative

Mckesson medical-surgical, inc.Is the assembler of convenience kits that can contain a syringe component from the manufacturer identified.The item ref # and lot # reported and identified has been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified (b)(6) for awareness.

• Brand Name: TKMD
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.; no.228 weiyi road economic dev; tianchang city, anhui 23930 0; CH 239300
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 13714846
• MDR Text Key: 289459844
• Report Number: 3017368639-2022-00010
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TKSLL-001
• Device Lot Number: 20210401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2022
• 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 Outcome(s): Other