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

Model Number 68248

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 10-oct-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, inc., 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, inc.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.(b)(4).

Event Description

It was reported that there were two holes on the middle and the edge of the wrap.After surgery, the customer noticed this issue.The customer stated that they are not sure if the holes were opened before use or after use.Additional information was received 18-sept-2018 that states, an email was received, hole was noticed post sterilization.Additional information was received 19-sept-2018 that states, the customer found holes after surgery.However, they were not sure if the hole opened up before sterilization.There was no patient injury.Additional information was received 25-sept-2018 that states there were no problem with the patient.

Event Description

It was reported that there were two holes on the middle and the edge of the wrap.After surgery, the customer noticed this issue.The customer stated that they are not sure if the holes were opened before use or after use.Additional information was received 18-sept-2018 that states, an email was received, hole was noticed post sterilization.Additional information was received 19-sept-2018 that states, the customer found holes after surgery.However, they were not sure if the hole opend up before sterilization.There was no patient injury.Additional information was received 25-sept-2018 that states there were no problem with the patient.

Manufacturer Narrative

One (1) used sample was received on september 18, 2018 for evaluation with no product packaging.The sample has sterilization indicator tape affixed to the anvil side of the sample.The sample was examined under ambient light conditions and exhibits a hole which measures approximately 6mm.The hole is observed in the area near a corner where a tray was possibly wrapped.Adjacent to the hole, the material is abraded and exhibits a smaller hole which appears as thinner material due to the abrasion.The holes were viewed under magnification.The hole as seen from the anvil side, exhibits a darkened edge.There is material missing from the area of the hole.The abraded area appears more fibrous from the anvil side.Due to the orientation of the fibers and material around the edges it is difficult to state from which side the hole originated.No root cause was identified.All information reasonably known as of 06nov2018 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, inc.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, inc.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, inc.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.

• Brand Name: SEQUENTIAL H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM)
• Type of Device: STERILIZATION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7950970
• MDR Text Key: 123841018
• Report Number: 1054380-2018-00004
• Device Sequence Number: 1
• Product Code: FRG
• UDI-Device Identifier: 20680651682486
• UDI-Public: 20680651682486
• Combination Product (y/n): N
• PMA/PMN Number: K082554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 68248
• Device Catalogue Number: 991068248
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1