MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; STOPCOCK HIGH PRESSURE

Catalog Number H965700550091

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Not Applicable (3189)

Event Date 11/02/2016

Event Type  malfunction  

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 stopcocks 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 root cause of the hole is the handle from the stopcock presses outward against the tyvek.As part of the receiving process at nipro (the distributor in (b)(4)), all pouched products are removed from their inner boxes and a nipro label (in (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 nipro warehouse employees.The hole in the tyvek was likely caused by the handle of a stopcock in the pouch, however, what caused the handle 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 nipro warehouse.- handling during nipro 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 ethylene oxide (eo) process.Do not use if sterile barrier is damaged." (b)(4).

Event Description

As reported by angiodynamics' distributor in (b)(4), in the distributor's warehouse a small hole was found in the tyvek portion of a stopcock pouch, breaching the sterility.The device had not been provided to a hospital, and was returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS
• Type of Device: STOPCOCK HIGH PRESSURE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6142790
• MDR Text Key: 61402632
• Report Number: 1317056-2016-00183
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: H965700550091
• UDI-Public: H965700550091
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K842829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: H965700550091
• Device Lot Number: 5064227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1