MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS; INTRODUCER, CATHETER

Model Number	IPN911881
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
During a picc insertion, the nurse began to peel away the glidethru sheath and half of the top portion of the sheath broke off prematurely.The rest of the sheath remained in place.No patient injury or complication reported.The patient's condition is reported as fine.
Event or Problem Description
During a picc insertion, the nurse began to peel away the glidethru sheath and half of the top portion of the sheath broke off prematurely.The rest of the sheath remained in place.No patient injury or complication reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The actual sample was not returned; however, the customer provided one photo for analysis.The photo confirmed that peel-away sheath did not split correctly.However, a full visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator or tissue dilator as this can lead to vessel perforation and bleeding.Do not withdraw tissue dilator until the sheath is well within vessel to reduce the risk of damage to sheath tip." the customer report of a sheath tearing incorrectly was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, 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 PICC KIT: 1-L 4.5 FR X 55 CM VPS
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11382113
• Report Number: 1036844-2021-00029
• Device Sequence Number: 4037601
• Product Code: DYB
• UDI-Device Identifier: 10801902134988
• UDI-Public: 10801902134988
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 12/31/2021
• Device Model Number: IPN911881
• Device Catalogue Number: ASK-45541-VFH
• Device Lot Number: 23F20H0344
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1