MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW DRAINAGE KIT; CATHETER IRRIGATION

Model Number	IPN036836
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Mdr report key: (b)(4).Mdr text key: (b)(4).Mdr report number: mw5101664.
Event or Problem Description
Complaint found in maude database reported as: "patient had a left percutaneous chest tube placed on (b)(6) 2021 by seldinger's technique.It has been in place since that time functional.Cxr on (b)(6) 2021 noted a worsening pneumothorax, but a wire density object was noted that did not correlate with a telemetry wire.Ultimately, this chest tube was exchanged for a different tube, and during the exchange a piece of the guidewire was identified at the end of the catheter while it was removed.Fda safety report id # (b)(4).".
Event or Problem Description
Complaint found in maude database reported as: "patient had a left percutaneous chest tube placed on (b)(6) 2021 by seldinger's technique.It has been in place since that time functional.Cxr on (b)(6) 2021 noted a worsening pneumothorax, but a wire density object was noted that did not correlate with a telemetry wire.Ultimately, this chest tube was exchanged for a different tube, and during the exchange a piece of the guidewire was identified at the end of the catheter while it was removed.Fda safety report id # (b)(4).".
Additional Manufacturer Narrative
(b)(4).Mdr report key: 11929586.Mdr text key: 254376084.Mdr report number: mw5101664.Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW DRAINAGE KIT
• Common Device Name: CATHETER IRRIGATION
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12300192
• Report Number: 9680794-2021-00396
• Device Sequence Number: 11754910
• Product Code: GBX
• UDI-Device Identifier: 50801902120156
• UDI-Public: 50801902120156
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K895516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 10/31/2022
• Device Model Number: IPN036836
• Device Catalogue Number: AK-01600
• Device Lot Number: 13F21B0235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED