MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR

Catalog Number	H965700300211
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/24/2016
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 (b)(4) february 2016 complaint report was reviewed for the product family of perceptor dt/manifold and the failure mode, "hole in sterile pouch." no adverse trends were identified.The returned sample was visually inspected and the hole in the pouch was confirmed.As part of the receiving process at (b)(4) (the distributor in (b)(4)), all pouched products are removed from their inner boxes and a (b)(4) label (in (b)(4)) is applied to each pouch.Additional handling may occur if the pouches are 100% visually inspected.The pouched product is then re-boxed into the inner box by the (b)(4) warehouse employees.The hole in the (b)(6) was likely caused by the handle of the device in the pouch, however, what caused the handle to be pushed against the (b)(6) 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 (b)(4) procedures during the sealing and final box processes.The directions for use (dfu) for the device contains the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged." (b)(4).
Event or Problem Description
As reported by (b)(4), hole in the product pouch was observed, which breached the sterility.The unused device had not been provided to a hospital, and was returned to (b)(4) for evaluation.

• Brand Name: ANGIODYNAMICS
• Common Device Name: TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5570604
• Report Number: 1317056-2016-00050
• Device Sequence Number: 405417
• Product Code: DRS
• UDI-Device Identifier: H965700300211
• UDI-Public: H965700300211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910764
• 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): 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: H965700300211
• Device Lot Number: 4969847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2016
• Initial Report FDA Received Date: 04/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1