MAUDE Adverse Event Report: ANGIODYNAMICS BIOSTABLE PICC; PERIPHERALLY INSERTED CENTRAL CATHETER,

Catalog Number	H965750171
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was a bio-flo picc kit.A visual examination of the return package noted a tear in the sterile package pouch.The customer's complaint event description is confirmed for tear in pouch.Although the complaint description is confirmed, a definitive root cause for the event cannot be determined.A potential root cause for this incident could be improper handling during the final box/tandem packaging process.A dhr search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The pouches are 100% inspected during the sealing process and final box process.The size of the tear in the pouch would be noticed during this process.Employees are being made aware of the complaint in order to improve their awareness of the defect and to improve the probability of identifying the defect in the future.A directions for use is supplied to the customer.The dfu contains a warning that states: contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your navilyst medical representative.Inspect prior to use to verify that no damage has occurred during shipping.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).
Event or Problem Description
When the user facility received shipment of biostable picc kits, and were unpacking the shipment, it was noted one of the pouches was cut in a v on the corner.There was a tear, compromising the product sterility.The reported package has been returned to the manufacturer for evaluation.

• Brand Name: BIOSTABLE PICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9009752
• Report Number: 1317056-2019-00119
• Device Sequence Number: 2377682
• Product Code: LJS
• UDI-Device Identifier: H965750171
• UDI-Public: H965750171
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: H965750171
• Device Lot Number: 5459118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1