MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. TRANSRADIAL ACCESS TRAY; INTRODUCER CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "during a procedure, after the intervention and during removal of the introducer, the nurse observed a small quantity of blood (leak) at the level of the junction between the base and the body of the introducer.
Event or Problem Description
It was reported that: "during a procedure, after the intervention and during removal of the introducer, the nurse observed a small quantity of blood (leak) at the level of the junction between the base and the body of the introducer.
Additional Manufacturer Narrative
Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of sheath leaked is not confirmed.No leaks were noted from the returned sheath.Although, the root cause of the complaint is undetermined the returned device passed visual and functional test specifications.No further action required at this time.

• Brand Name: TRANSRADIAL ACCESS TRAY
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8207747
• Report Number: 3010532612-2018-00398
• Device Sequence Number: 18898387
• Product Code: DYB
• UDI-Device Identifier: 00801902066626
• UDI-Public: 00801902066626
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: AA-10507-1
• Device Lot Number: 14F18E0297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1