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	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as: customer reported picc broke/separated from hub.Patient came in to get the catheter removed via surgery and had another line placed.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for evaluation.Visual examination of the photo revealed the catheter body was separated adjacent to the juncture hub.A small portion of the catheter body remained secured to the hub.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 provided with this kit warns the user, "do not secure , staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce the risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of catheter body separation 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.
Event or Problem Description
The complaint is reported as: customer reported picc broke/separated from hub.Patient came in to get the catheter removed via surgery and had another line placed.The patient's condition is reported as fine.

• 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: 12135302
• Report Number: 9680794-2021-00322
• Device Sequence Number: 4679122
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 01/31/2022
• Device Model Number: IPN911881
• Device Catalogue Number: ASK-45541-VFH
• Device Lot Number: 13F20L0087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention