MAUDE Adverse Event Report: 10 CC CONTAMINATION SHEATH SYRINGE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	42052-01
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device is expected for evaluation, it has not yet been received.
Event or Problem Description
The event involved a 10 cc contamination sheath syringe where the syringe tip cracked inside the transducer stand and the syringe then pulled back air.There was no adverse event and no report of human harm.
Event or Problem Description
The customer reported that there was patient involvement and that the broken tubing was noticed during infusion.There was no leaking; however it was identified that air was being pulled into setup.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
One used 10 cc contamination sheath syringe was returned for investigation.The reported complaint of a cracked syringe tip was confirmed.Two images were provided by the customer showing the syringe and the tip of the syringe.The returned sample matches the configuration of the syringe.However, the tip of the syringe has some plastic deformation.The plastic deformation would lead to air bubbles or a leak.The device history records (dhrs) for the lot number and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 10 CC CONTAMINATION SHEATH SYRINGE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11824543
• Report Number: 9617594-2021-00160
• Device Sequence Number: 13718000
• Product Code: DQO
• UDI-Device Identifier: 00887709042759
• UDI-Public: (01)00887709042759(17)231101(10)5093306
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K932141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2021

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: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 42052-01
• Device Catalogue Number: 42052-01
• Device Lot Number: 5093306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 08/26/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/15/2021; 09/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSDUCER STAND, MFR UNK; UNSPECIFIED MEDICATION, MFR UNK