MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. 150 FASTURN SYRINGE KIT W/QFT; ANGIOGRAPHIC SYRINGE KIT

Model Number	60729393
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information, we are unable to determine the root cause of the unknown particles at this time; however, the products are scheduled to return to bayer for a full evaluation.Once the evaluation is completed, a follow-up report will be submitted.
Event or Problem Description
The customer reported the following: after opening several arterion disposable syringe kits and upon inspection, they noticed the presence of fine white particles around the syringes as well as the quick fill tubes (qft).The customer elected not to use the syringe kits.No injury or adverse event was reported.
Additional Manufacturer Narrative
Bayer product analysis received and examined 2 returned syringe kits.Visual examination confirmed the presence of a fine, white powdery substance that was concentrated near the drop front alignment key on the neck of the syringes.Traces of the white powdery substance were also observed within the polystyrene trays.Further examination of the polystyrene trays found abrasions where the syringes came in contact with the tray.Examination of retained samples for this lot number did not confirm the presence of the reported white powdery substance.Product analysis determined that most likely during shipping/handling, the movement of the syringes against the polystyrene tray caused material to flake off and settle within the disposable kit.A review of complaint history found that the subject complaint is the only complaint reported against this lot number.A 12 month review of complaint history determined the complaint rate to be 1.9 complaints per million (cpm).

• Brand Name: 150 FASTURN SYRINGE KIT W/QFT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 7117715
• Report Number: 2520313-2017-00081
• Device Sequence Number: 1799211
• Product Code: DXT
• UDI-Device Identifier: 00616258007847
• UDI-Public: (01)00616258007847(11)170503
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113133
• 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,Followup
• Report Date (Section B): 02/02/2018

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: 05/03/2019
• Device Model Number: 60729393
• Device Catalogue Number: ART 700 SYR
• Device Lot Number: 8405541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1