MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYANMICS / PROTECTION STATION PLUS; INTRAVENOUS ADMINISTRATION SET

Catalog Number	H965640009351
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The angiodynamics (b)(6) 2016 complaint report was reviewed for the closed system product family and the failure mode,"hole in pouch." no adverse trends were identified.The returned sample was visually inspected and the hole in the pouch was confirmed.The hole was caused by the edge of the roller clamp assembly.There is an approx.1/8" slice in the tyvek side of the pouch that aligns with the edge of the roller clamp.As part of the receiving process at (b)(4) ((b)(4)), all pouched products are removed from their inner boxes and a (b)(4) label ((b)(4)) is applied to each pouch.Additional handling may occur if product is 100% visually inspected.The pouched product is then re-boxed into the inner box by the (b)(4) warehouse employees.The hole in the tyvek was likely caused by the edge of the roller clamp, however, what caused the roller clamp to be pushed against the tyvek in a manner that resulted in a hole cannot be determined.Potential contributing factors include: handling of the pouches as they are placed in the inner boxes.Handling during transit to (b)(4) warehouse.Handling during (b)(4) labeling/inspection and re-boxing process.All pouches are 100% inspected per angiodynamics procedures during the sealing and final box processes.The directions for use (dfu) packaged with the kits contain the following warning: "contents supplied sterile using an (b)(4) process.Do not use if sterile barrier is damaged." ((b)(4)).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), in the distributor's warehouse a small hole was found in the tyvek portion of the closed fluid system pouch, breaching the sterility.The product had not been provided to a hospital and was returned to angiodynamics for evaluation.

• Brand Name: ANGIODYANMICS / PROTECTION STATION PLUS
• Common Device Name: INTRAVENOUS ADMINISTRATION SET
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5529865
• Report Number: 1317056-2016-00046
• Device Sequence Number: 516989
• Product Code: FPA
• UDI-Device Identifier: H965640009351
• UDI-Public: H965640009351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K852140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2016

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: 12/31/2018
• Device Catalogue Number: H965640009351
• Device Lot Number: 4963977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Initial Report FDA Received Date: 03/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1