MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Catalog Number CDC-45552-VPS2

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the kit is not sealed.Sterility is broken.The issue was detected prior to patient use.

Event Description

The customer reports that the kit is not sealed.Sterility is broken.The issue was detected prior to patient use.

Manufacturer Narrative

(b)(4).The customer did not return the sample; however, they did provide a photo for evaluation.Visual examination confirmed the lidstock was partially separated along one side of the finished kit.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "sterile, single use: do not reuse, reprocess or re-sterilize.Reuse of device creates a potential risk of serious injury and/or infection which may lead to death." the customer report of an improperly sealed kit was confirmed by visual examination of the customer supplied photo.The lidstock was partially separated from the tray along one side.A device history record review was performed with no relevant findings.Based on the complaint description and photo, packaging (sealing) caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.

Event Description

The customer reports that the kit is not sealed.Sterility is broken.The issue was detected prior to patient use.

Manufacturer Narrative

(b)(4).The customer returned one kit for evaluation.Visual examination confirmed a sufficient seal along the circumference of the kit.The pffs pouch was attached to the kit, indicating that the customer removed the pouch and reattached it before returning.No other defects were detected.A non-conformance request was originally initiated to further investigate this issue.The packaging investigation confirmed that the seal contained sufficient adhesive transfer and the defect would have been detected prior to customer receipt.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "sterile, single use: do not reuse, reprocess or re-sterilize.Reuse of device creates a potential risk of serious injury and/or infection which may lead to death." the customer report of a broken seal was confirmed by complaint investigation of the returned photo and sample.However, in the photo, the pffs pouch was removed, and the sample received contained the pffs pouch.This indicates that the customer removed the pouch, which can potentially cause the seal to break open.Based on the sample returned and packaging investigation, the probable cause of this complaint could not be determined as it is unknown when the sterility breach occurred.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Type of Device: CATHETER INTRAVSCULAR THERAPEU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8869887
• MDR Text Key: 175030323
• Report Number: 1036844-2019-00872
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K153487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2019

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 Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 23F19A0385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 12/13/2019
• Supplement Dates FDA Received: 09/09/2019; 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.; UNKNOWN.