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

Model Number	84192961
Medical Device Problem Codes	Product Quality Problem (1506); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined two returned syringes from the syringe kit.Visual examination confirmed the presence of a particle within the syringe barrel of one syringe.The second syringe showed no evidence of any particulate present.The particle was found to be a translucent, plastic-like material.Our investigation determined that the particle noted in the syringe was introduced during the manufacturing process.A 12 month review of complaint history determined the complaint rate to be (b)(4).
Event or Problem Description
The site reported the following: white particles were seen in the syringe barrel of a sds-ctp-spk syringe kit.The kit was removed from the area and was not used for a patient.

• 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: 7828239
• Report Number: 2520313-2018-00059
• Device Sequence Number: 1808572
• Product Code: DXT
• UDI-Device Identifier: 00616258007045
• UDI-Public: (01)00616258007045
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 08/29/2018

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: 06/26/2022
• Device Model Number: 84192961
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8546569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1