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

Model Number	60728818
Medical Device Problem Codes	Clumping in Device or Device Ingredient (1095); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined one returned low pressure connector tubing (lpct).Visual examination confirmed the presence of a particle within the tube set.The particle was identified as degraded resin from the tubing extrusion process and was partially connected to the inside wall of the tubing.Our investigation determined that the particle noted in the lpct was introduced during the manufacturing process.A 12 month review of complaint history determined the complaint rate to be (b)(4) complaints per million (cpm).
Event or Problem Description
The site reported the following: a stellant disposable set has visible foreign material in the tubing.This is a sss-cpt-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: 7510600
• Report Number: 2520313-2018-00042
• Device Sequence Number: 11109038
• Product Code: DXT
• UDI-Device Identifier: 00616258005218
• UDI-Public: (01)00616258005218
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: 60728818
• Device Catalogue Number: SSS-CTP-SPK
• Device Lot Number: 8542858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1