MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; CATHETER, PERCUTANEOUS

Catalog Number	UM-04018
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: " pt had a femoral aline which was inserted in the icu on 9/5.Aline site with significant bleeding overnight (b)(6) to (b)(6) but still with a good waveform and readings.(b)(6) am, more significant bleeding and clots noted at site.Per md - bedside rn and second rn attempted to remove the a-line.Site very bloody with poor visualization of the actual insertion point but able to see the wings with the sutures well.Sutures were removed and a-line catheter gently pulled out.Rns noted that only a small piece of the catheter was present.After bleeding stopped, unable to see any other fragment of the catheter.The other portion of the catheter is still indwelling in the femoral vein.The patient may be having it removed in interventional radiology soon." awaiting additional information from the customer.
Additional Manufacturer Narrative
(b)(4).The customer returned one arterial catheter and connector tubing with stopcock for analysis.Signs-of-use were observed on both components.Visual analysis revealed that the catheter body was severed towards the juncture hub.The separated end was not returned for analysis.Microscopic examination confirmed the damage and revealed that the point of separation was smooth, uniform, and angled, which is damage consistent with contact with a sharp object (i.E.Scalpel, scissors, sutures, etc).No other defects or anomalies were observed.The point of separation measured 4mm from the juncture hub.The catheter body outer diameter measured 0.0565", which is within the specification limits of 0.0550"-0.0590" per the catheter extrusion product drawing.The inner diameter at the point of separation and from inside the catheter hub measured 0.037", which is within the specification limits of 0.037"-0.039" per the catheter extrusion product drawing.The catheter length cannot be verified as the separation portion was not returned for analysis.Functional testing was not required as part of this complaint investigation.R & d was contacted as part of this complaint investigation.They confirmed that the separation appears consistent with the catheter being cut by a sharp object (i.E.Scissors).All complaints are trended across product families on a monthly basis per complaint trending global work instruction.Therefore, a separate complaint history review is not required.A device history record review was performed, and no relevant findings were identified.The report of a separated arterial catheter was confirmed through analysis of the returned sample.Visual analysis confirmed that the catheter body was severed towards the hub.The appearance of the separation was angled, smooth, and uniform and consistent with damage resulting from contact with a sharp instrument (i.E.Scisssors, scalpel, etc.).Despite the damage, the catheter body outer and inner diameter measured within specification; however, the catheter body length could not be verified as the separated portion was not returned.A device history record review was performed, and no relevant findings were identified.Based on the customer report that the damage was observed during use and appearance of the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: " pt had a femoral aline which was inserted in the icu on 9/5.Aline site with significant bleeding overnight 9/7 to 9/8 but still with a good waveform and readings.9/9 am, more significant bleeding and clots noted at site.Per md - bedside rn and second rn attempted to remove the a-line.Site very bloody with poor visualization of the actual insertion point but able to see the wings with the sutures well.Sutures were removed and a-line catheter gently pulled out.Rns noted that only a small piece of the catheter was present.After bleeding stopped, unable to see any other fragment of the catheter.The other portion of the catheter is still indwelling in the femoral vein.The patient may be having it removed in interventional radiology soon." awaiting additional information from the customer.
Additional Manufacturer Narrative
Qn# (b)(4).Medwatch received 03-oct-2024 # (b)(4).

• Brand Name: ARROW ACCESS TRAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20342585
• Report Number: 9680794-2024-00959
• Device Sequence Number: 7805001
• Product Code: DQY
• UDI-Device Identifier: 10801902118889
• UDI-Public: (01)10801902118889(11)230125(17)250430(10)13F23A0172(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: UM-04018
• Device Lot Number: 13F23A0172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White