MAUDE Adverse Event Report: O&M HALYARD INC. QUICK CHECK* H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM); STERILIZATION PRODUCTS

Model Number	34145
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard.O&m halyard,inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc., product is defective or caused serious injury.
Event or Problem Description
It was reported that there were holes fond on the white side of the sterilization wrap.The holes were detected after use.Additional information was reported on (b)(6) 2018 that sttes, "the objects which wrapped with the product in question and sterilized wre used to the patient but no patient injury reported".
Additional Manufacturer Narrative
The device was reported to be available for return.However, the sample was not returned for evaluation.All information reasonably known as of 25october2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by (b)(4) represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to (b)(4).(b)(4) has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the (b)(4) complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a (b)(4) product is defective or caused serious injury.
Event or Problem Description
It was reported on 25-sept-2018 that the sample was not available for return.It was reported that there were holes fond on the white side of the sterilization wrap.The holes were detected after use.Additional information was reported on 30-aug-2018 that states, "the objects which wrapped with the product in question and sterilized were used to the patient but no patient injury reported".

• Common Device Name: STERILIZATION PRODUCTS
• Manufacturer (Section D): O&M HALYARD INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7897689
• Report Number: 1054380-2018-00003
• Device Sequence Number: 1434485
• Product Code: FRG
• UDI-Device Identifier: 20680651341451
• UDI-Public: 20680651341451
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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 Model Number: 34145
• Device Catalogue Number: 991034145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1