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

Model Number	8881512258
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	Insufficient Information (4580)
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: the ridges of the plunger does not seal.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Seven photos were provided for review however, the reported condition could not be confirmed from the picture alone.One physical sample was received for evaluation.The affected component is produced by another site; the assembly process only consists in a pick and place operation for this material.There is no additional inspection on the line to detect the condition reported.The returned sample and a complaint notification was sent to the other site to initiate additional investigating.That investigation is currently pending.Once available, the findings will be updated accordingly and a follow up report will be sent.

• 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: 12170450
• Report Number: 9612030-2021-02987
• Device Sequence Number: 14633881
• 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