MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 2-L: 5.5FR X 15CM; MIDLINE CATHETER

Model Number	IPN037698
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: when breaking the sheath, one side arm detached from the sheath.The nurse was able to continue to peel the sheath without the side arm.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: when breaking the sheath, one side arm detached from the sheath.The nurse was able to continue to peel the sheath without the side arm.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for evaluation.The sheath contained obvious signs of use in the form of biological material.Visual examination revealed one sheath tab was separated from the sheath.A portion of the sheath body remained within the hub.The separation points appeared rough and jagged, which is damage consistent with undue force being applied while the hub is pulled up instead of splitting to the sides.The total length of the sheath body measured to be 2 13/16" which is within specifications of 2 5/8"- 2 7/8" per product drawing.The peel-away sheath was able to fully split along the score lines as described in the instructions-for-use.A manual tug test confirmed the remaining tab was fully secured to the sheath body.Manufacturing engineering was consulted to evaluate the sample returned by the customer for potential manufacturing causes.Per manufacturing, based upon the sample returned and the customer report, unintentional use error likely caused or contributed to this defect.A device history record review was performed with no relevant findings.The ifu provided with this kit instruct the user, "grasp tabs of peel away sheath and pull apart, away from the catheter, while withdrawing from vessel until sheath splits down its entire length." the customer report of a separated sheath tab was confirmed by complaint investigation of the returned sample.The damage observed was consistent with undue force applied.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.Based on the condition of the sample received and feedback from engineering , unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AM/AT PI MIDLINE 2-L: 5.5FR X 15CM
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11719421
• Report Number: 9680794-2021-00177
• Device Sequence Number: 14459608
• Product Code: PND
• UDI-Device Identifier: 50801902130162
• UDI-Public: 50801902130162
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• 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): 04/06/2021

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: No Information
• Device Expiration Date: 03/31/2022
• Device Model Number: IPN037698
• Device Catalogue Number: CDC-41552-MPK1A
• Device Lot Number: 13F20M0584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1