MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: THERMISTOR 7 110CM; CATHETER, FLOW DIRECTED

Model Number	IPN000099
Medical Device Problem Codes	No Device Output (1435); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after insertion of the catheter the connectors on the devices were not working.As a result, device was removed and replaced with a different brand.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the "connectors on device didn't work" is not able to be confirmed.The root cause of the complaint is undetermined.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported that after insertion of the catheter the connectors on the devices were not working.As a result, device was removed and replaced with a different brand.There was no report of patient complications, serious injury or death.

• Brand Name: CATH PKGD: THERMISTOR 7 110CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9863503
• Report Number: 3010532612-2020-00072
• Device Sequence Number: 16862475
• Product Code: DYG
• UDI-Device Identifier: 00801902004567
• UDI-Public: 00801902004567
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K823433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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 Model Number: IPN000099
• Device Catalogue Number: AI-07167
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 03/21/2020
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1