MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. SPECTRIS SOLARIS SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT

Model Number	60728567
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received a photo of the affected syringe.Visual examination confirmed a hair-like particulate within the syringe barrel.Our investigation determined that the particulate noted in the syringe was likely introduced during the component manufacturing or assembly process.A 12 month review of complaint history demonstrated a frequency of 0.21 complaints per million for particulate inside a syringe barrel.
Event or Problem Description
The customer reported the following: after opening a ssqk 65/115vs syringe kit, a hair was observed within the syringe barrel.There was no adverse event or injury.

• Brand Name: SPECTRIS SOLARIS SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 9296430
• Report Number: 2520313-2019-00052
• Device Sequence Number: 2223671
• Product Code: DXT
• UDI-Device Identifier: 00616258005423
• UDI-Public: (01)00616258005423
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K012950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/08/2019

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: 09/10/2024
• Device Model Number: 60728567
• Device Catalogue Number: SSQK 65/115VS
• Device Lot Number: 8411998
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1