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
A device history record revealed no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Six photos were provided for review.In 2 of the photos it is observed that the syringe has contamination.One physical monoject syringe with 12ml liquid without the original package or lot number identification was also received for evaluation.The component is produced by an external supplier and the assembly process consists of a pick and place operation at the cardinal health facility.The root cause for the condition was requested from the manufacturer.The results are currently pending.There is no additional inspection on the line to detect the reported condition.We are awaiting an action plan to be implement by the supplier for the corrective actions.The cardinal health facility will continue monitoring the process for any adverse trends that require immediate attention.

• 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: 12170143
• Report Number: 9612030-2021-02982
• Device Sequence Number: 17324566
• 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): 10/22/2021

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: 2030104764
• 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: 10/22/2021
• Patient Sequence Number: 1