MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. STELLANT CT SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT

Model Number	60728753
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned syringe set.Visual examination of the returned product confirmed the presence of a foreign material in the syringe barrel.A hair-like particulate, measuring approximately 30 mm in length, was found in the syringe barrel.Our investigation determined that the particulate noted in the syringe was likely introduced during the component manufacturing or assembly process.A 12 month review of complaint history demonstrated a frequency of 0.43 complaints per million for particulate inside a syringe barrel.
Event or Problem Description
The site reported the following: the technician stated that she observed a filiform foreign body inside the syringe during the saline infusion process.There was no injury.

• Brand Name: STELLANT CT SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• MDR Report Key: 8683070
• Report Number: 2520313-2019-00027
• Device Sequence Number: 2256954
• Product Code: DXT
• UDI-Device Identifier: 00616258007939
• UDI-Public: (01)00616258007939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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 Expiration Date: 11/13/2022
• Device Model Number: 60728753
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8552826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1