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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The nurse had difficulty threading the catheter through the sheath.The sheath and dilator were inserted in the vessel.The dilator was removed and the catheter would not go through the sheath.The nurse was unable to finish insertion.A trialysis catheter was placed the next day.No patient injury or complication reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 2-lumen picc and peel-away sheath for evaluation.Visual examination of the sheath revealed slight damage adjacent to the hub.The damage appeared consistent with forceps holding the sheath body.Visual examination of the catheter did not reveal any defects or anomalies.The outer diameter of the returned catheter measured to be 0.074" which is within specifications of 0.069-0.074" per product drawing.The inner diameter of the proximal end of the returned sheath measured to be 0.083" which is greater than the minimum specifications of 0.079" per product drawing.The inner diameter of the distal tip of the returned sheath measured to be 0.077" which is within specifications of 0.077-0.078" per product drawing.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "insert catheter through peel-away sheath to final indwelling position.Retract and/or gently flush while advancing catheter if resistance is met." the returned catheter was advanced through the returned sheath with minimal resistance.The catheter and sheath were also dimensionally and functionally tested.Several catheter outer diameter measurements were taken using a laser micrometer and the maximum outer diameters were all in a range that would fit through the sheath tip inner diameter.Additionally, functional testing confirmed that minimal resistance was met when advancing the catheter through the sheath.A device history record review was performed with no relevant findings.The customer report of catheter/sheath resistance could not be confirmed by complaint investigation of the returned sample.The catheter and sheath passed all relevant dimensional and functionally testing, and a device history record review was performed with no relevant findings.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The nurse had difficulty threading the catheter through the sheath.The sheath and dilator were inserted in the vessel.The dilator was removed and the catheter would not go through the sheath.The nurse was unable to finish insertion.A trialysis catheter was placed the next day.No patient injury or complication reported.The patient's condition is reported as fine.

• 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: 11439273
• Report Number: 9680794-2021-00090
• Device Sequence Number: 3287203
• 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): 02/23/2021

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: 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: 03/02/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1