MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM PICC SET: 2-L 5.5FR X 55CM 80CM HYDRO; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN033540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Picc was difficult to push into the sheath introducer, at time of removal one wing broke from the peel-away sheath.No patient harm reported.
Event or Problem Description
Picc was difficult to push into the sheath introducer, at time of removal one wing broke from the peel-away sheath.No patient harm reported.
Additional Manufacturer Narrative
(b)(4), the customer returned one peel-away sheath and a lidstock for evaluation.No definite signs-of-use were observed.Visual analysis revealed that one sheath tab was separated from the extrusion.A portion of the sheath body was still molded to the tab.Microscopic examination revealed that the separation points were rough and jagged.Microscopic examination of the intact half of the peel-away revealed a small divot directly adjacent to point where the extrusion meets the tabs.This divot was evident from either side of the extrusion, and appears consistent with a manufacturing defect.The score lines appeared to have a uniform tear completely down the extrusion.The total length of the sheath body measured to be 4 1/8", which is within the specification limits of 3 7/8"-4 1/8" per the peel-away graphic.Manufacturing was consulted in regards to this defect and it was noted that the defect potentially could have occurred during manufacturing.A device history record review was performed, and findings were identified.Non-conformances were initiated to address the issue of interference with catheter body and id of peel-away sheath; however, it was determined that these issues are not linked as the observed damage does not appear to be caused as a result of catheter/sheath interference.The ifu provided with the kit informs the user, "grasp tabs of peel-away sheath and pull apart, away from catheter, until sheath splits down entire length".The customer report of a separated sheath tab was confirmed by complaint investigation of the returned sample.Visual analysis revealed that one half of the sheath had separated directly adjacent to the tab.Microscopic examination of the intact half revealed a small divot that was visible from both the outside and inside of the extrusion.The sample passed all relevant dimensional testing.A device history record review was performed, and a no relevant findings were identified.Based on the condition of the sample received and the customer report, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AM PICC SET: 2-L 5.5FR X 55CM 80CM HYDRO
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11931571
• Report Number: 9680794-2021-00267
• Device Sequence Number: 3363615
• Product Code: LJS
• UDI-Device Identifier: 00801902095787
• UDI-Public: 00801902095787
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 08/31/2022
• Device Model Number: IPN033540
• Device Catalogue Number: PR-45552-HPHNM
• Device Lot Number: 13F20L0602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1