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	Not Applicable (3189)
Date of Event	09/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis reviewed the photographs provided by the customer and confirmed the presence of a foreign material in the syringe barrel.In addition, the suspect product returned for evaluation.The foreign material present in the syringe barrel is white in color and appears to be plastic-like material.Our investigation determined that the particle noted in the syringe was likely introduced during the component manufacturing or assembly process.A 12 month review of complaint history determined a frequency of (b)(4).
Event or Problem Description
The site reported the following: a nurse reported that a white foreign particle was found inside one of the syringes in a sds-ctp-spk kit.The kit was not used for a patient and was removed from the area to be returned for investigation.

• 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: 7999447
• Report Number: 2520313-2018-00070
• Device Sequence Number: 1301909
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 05/06/2022
• Device Model Number: 60728753
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8544924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1