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

Model Number 60729369

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

Bayer quality assurance product analysis received and examined the returned syringe, lot #8538830.Visual examination of the returned product confirmed the presence of a strand of hair-like particle in the syringe barrel.The hair-like material was most likely introduced during the manufacturing process.A 12 month review of complaint history determined the frequency to be (b)(4) complaints per million (cpm) for similar defects.

Event Description

The site reported the following: a stellant sds-ctp-scs syringe was filled with contrast medium using a spike into the contrast medium vial and after filling a hair-like foreign particle was noted to be floating in the contrast inside the syringe.The syringe kit was removed from the area and was not used for a patient.

• Brand Name: STELLANT CT SYRINGE KIT
• Type of Device: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: linda mcdonald ; one bayer drive; indianola, PA 15051 ; 7249407412
• MDR Report Key: 7330736
• MDR Text Key: 102227340
• Report Number: 2520313-2018-00027
• Device Sequence Number: 1
• Product Code: DXT
• UDI-Device Identifier: 00616258005256
• UDI-Public: (01)00616258005256
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2022
• Device Model Number: 60729369
• Device Catalogue Number: SDS-CTP-SCS
• Device Lot Number: 8538830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1