MAUDE Adverse Event Report: CARDINAL HEALTH 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON

Model Number	8881512258
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
Customer reports: when filling the syringes, there are black particles found in some of the syringes and white particles in other syringes from the lot.The customer sent the product to a 3rd party lab for analysis and the white fibers were identified as cellulose with silicone and oxygen-rich surface particles and the black fiber defects were identified as textile cotton fibers with spectral indications of silicone.
Additional Manufacturer Narrative
Additional information: section h6 health effect - clinical code added.The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The product was manufactured on may 21, 2019.A tray of 25 unused syringes with lot number 1913424864 was received at the manufacturing site for the investigation.The samples were evaluated, and the reported issue was confirmed; white contamination was observed.The affected component is produced by an external supplier; our assembly process consists only of a pick and place operation for this material.As a result, the samples have been forwarded to the supplier along with an investigation request.The results of their investigation will be documented and shared when available.

• Brand Name: 12ML LUER LOCK TIP PHARM TRAY
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12170269
• Report Number: 9612030-2021-02985
• Device Sequence Number: 4724740
• Product Code: FMF
• UDI-Device Identifier: 10884521010970
• UDI-Public: 10884521010970
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: No Information
• Device Model Number: 8881512258
• Device Catalogue Number: 8881512258
• Device Lot Number: 1913424864
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1