MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS

Catalog Number	ES-04706
Medical Device Problem Codes	Unsealed Device Packaging (1444); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It is reported that: a small hole was found in the packaging which resulted in the device not being sterile.It was identified prior to use.There was no patient involvement.It was decided that the complaint was reportable after investigation of the returned device.
Additional Manufacturer Narrative
(b)(4).The customer returned one, unopened cvc kit for analysis.The seal along the outer edge of the lidstock was intact and uniform along the tray.Visual analysis revealed that the kit lidstock and tray contained a sterility breach in the form of a small hole.Microscopic examination confirmed the hole on both the lidstock and the tray.Both were observed to be in the top-right corner of the tray.It is being assumed that the damage to the lidstock also caused the damage to the tray.The packaging facility was contacted as part of this complaint investigation.They confirmed that the damage likely occurred after the kit was sealed; however, there are no process steps in the packaging process that typically result in the damage observed.The distribution centers (edc rhenus and ap07) were also contacted as part of this complaint investigation.In edc rhenus, they confirmed that this finished good shows no record of repackaging.Likewise, there is no record of this finished good showing such damage during their handling.In ap07, they confirmed that chinese labels are placed on the lidstocks of the kits; however, there is no process that can cause this type of damage.A dev ice history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a sterility breach was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the kit lidstock and tray contained a sterility breach in the form of two small holes.Based on the comments from the packaging facility and the distribution centers for this finished good, this type of damage has not been observed as part of the normal packaging/handling process.Additionally, there are inspections in place to check for such damage.Based on the customer report, the sample received, and the comments from packaging/distribution, storage/shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It is reported that: a small hole was found in the packaging which resulted in the device not being sterile.It was identified prior to use.There was no patient involvement.It was decided that the complaint was reportable after investigation of the returned device.
Event or Problem Description
It is reported that: a small hole was found in the packaging which resulted in the device not being sterile.It was identified prior to use.There was no patient involvement.It was decided that the complaint was reportable after investigation of the returned device.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi #.Udi related data quality updates only.

• Brand Name: ARROW CVC SET: 14 GA X 6" (16 CM)
• Common Device Name: CATHETER PERCUTANEOUS
• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18072812
• Report Number: 3006425876-2023-01133
• Device Sequence Number: 7759606
• Product Code: DQY
• UDI-Device Identifier: 00801902108418
• UDI-Public: (01)00801902108418(11)220609(17)270531(10)71F22F1708(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• 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): 10/31/2023

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 Catalogue Number: ES-04706
• Device Lot Number: 71F22F1708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 12/04/2023; Not provided
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/05/2023; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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