MAUDE Adverse Event Report: CARDINAL HEALTH 140ML SYR LUER LOCK TIP; SYRINGE, PISTON

Model Number	8881114030
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that there was air in the line.The customer reported that during morning qc, air was consistently being pulled into the pump syringe upon refilling it.The customer did not notice anything out of the ordinary to cause air in the pump syringe.Per additional information received, after swapping out the accessory package with a new one, everything was functioning normally again.There was no medical intervention given.
Additional Manufacturer Narrative
Investigation summary: the device history record (dhr) was not reviewed because the lot number reported does not correspond to the product code reported.One sample was received at the manufacturing site.A visual inspection and functional testing were performed.The reported condition could not be reproduced.The reported issue could not be confirmed.The sample received does not present the condition reported by the customer.A root cause could not be identified.No action plan is required at this time.This complaint will be used for tracking and trending purposes.D4 lot number: the lot number reported by the customer was incorrect.The lot number reported does not correspond to the product code mentioned.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.D4 model number and catalog number have been corrected per information received from the customer.

• Brand Name: 140ML SYR LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13996913
• Report Number: 9612030-2022-03201
• Device Sequence Number: 4339688
• Product Code: FMF
• UDI-Device Identifier: 20884521128917
• UDI-Public: 20884521128917
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2022

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
• Device Model Number: 8881114030
• Device Catalogue Number: 8881114030
• Device Lot Number: 1912703064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 03/11/2022; 03/11/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/18/2022; 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown