MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CV-47702-E
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: (b)(6) 2023, the doctor found that the kit was not sealed properly.The issue was identified prior to use.There was no patient involved.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: (b)(6) 2023, the doctor found that the kit was not sealed properly.The issue was identified prior to use.There was no patient involved.
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cvc kit for evaluation.No definite signs of use were observed.Visual analysis revealed that the kit tray was severely damaged and the lidstock was not entirely sealed to the tray.Observation of the tray revealed that the tray adhesive seemed sparse in certain locations of the flange, but further consultation with the packaging facility confirmed that the amount of adhesive was acceptable.Severe damage to the tray both on the body and along the edges was also noted.The ars tip was observed to be damaged.Due to the extensive damage, clarification was requested from the customer to provide additional details and they confirmed that the kit wasn't entirely sealed and that the "tray was severely crushed/deformed".This, they stated, also likely contributed to the observed ars damage.The packaging and distribution facilities were consulted as part of this complaint investigation.Packaging stated that the adhesive observed on the tray was an acceptable amount based on a heat seal visual inspection conducted.Therefore, it likely would not contribute to the damage.Damage to the chinese label on the lidstock was also noted.The distribution facility stated that the damage could be present during transportation or labelling, but not during operations in the distribution center.A device history record review was performed, and no relevant findings were identified.The customer report of a damaged kit seal was confirmed through investigation of the returned sample.Visual analysis revealed that the kit tray was severely damaged.The packaging and distribution facilities were consulted, and they stated that the damage is more consistent with the transportation during shipping and storage.Therefore, based on the customer report and sample received, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-(udi)# corrected to (b)(4).The customer returned one opened cvc kit for evaluation.No definite signs of use were observed.Visual analysis revealed that the kit tray was severely damaged and the lidstock was not entirely sealed to the tray.Observation of the tray revealed that the tray adhesive seemed sparse in certain locations of the flange, but further consultation with the packaging facility confirmed that the amount of adhesive was acceptable.Severe damage to the tray both on the body and along the edges was also noted.The ars tip was observed to be damaged.Due to the extensive damage, clarification was requested from the customer to provide additional details and they confirmed that the kit wasn't entirely sealed and that the "tray was severely crushed/deformed".This, they stated, also likely contributed to the observed ars damage.The packaging and distribution facilities were consulted as part of this complaint investigation.Packaging stated that the adhesive observed on the tray was an acceptable amount based on a heat seal visual inspection conducted.Therefore, it likely would not contribute to the damage.Damage to the chinese label on the lidstock was also noted.The distribution facility stated that the damage could be present during transportation or labelling, but not during operations in the distributi on center.A device history record review was performed, and no relevant findings were identified.The customer report of a damaged kit seal was confirmed through investigation of the returned sample.Visual analysis revealed that the kit tray was severely damaged.The packaging and distribution facilities were consulted, and they stated that the damage is more consistent with the transportation during shipping and storage.Therefore, based on the customer report and sample received, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: 25 sep 2023, the doctor found that the kit was not sealed properly.The issue was identified prior to use.There was no patient involved.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17975046
• Report Number: 3006425876-2023-00996
• Device Sequence Number: 2491696
• Product Code: FOZ
• UDI-Device Identifier: 10801902102536
• UDI-Public: (01)10801902102536(11)220922(17)240829(10)71F22J1153(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2023

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
• Device Expiration Date: 08/29/2024
• Device Catalogue Number: CV-47702-E
• Device Lot Number: 71F22J1153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 02/05/2024; Not provided
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 02/06/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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; NOT REPORTED
• Patient Sex: Unknown