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

Model Number	84192961
Medical Device Problem Codes	Material Disintegration (1177); Material Integrity Problem (2978)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined 3 returned syringe kits.Visual examination confirmed the presence of white particles in the returned kit.Further evaluation determined that the white particles were concentrated near the syringe drip flanges and there were traces of the particulates within the styrene tray.Also noted were abrasions to the tyvek covers at the point of contact for the syringe drip flanges.Product analysis determined that the cause of the reported particulate is abrasive action between the syringe barrel drip flange and tyvek cover.A 12 month review of complaint history determined a frequency of 0.06 complaints per million.
Event or Problem Description
The site reported the following: a radiology technologist reported that upon opening 3 sds-ctp-spk syringe kits from the same box, a white powder was observed on the syringes.The kits were not used for a patient and were removed from the area, being saved 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: 8321875
• Report Number: 2520313-2019-00004
• Device Sequence Number: 1780274
• Product Code: DXT
• UDI-Device Identifier: 00616258007045
• UDI-Public: (01)00616258007045
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/08/2019

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: 11/07/2022
• Device Model Number: 84192961
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8552768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1