MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB004

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

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

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The product involved in the report has been returned and is being processed for evaluation.A review of the device history record was conducted for lot 0202409740.According to the results, the production lot met all manufacturing and quality specifications.Investigation including root cause analysis is in progress.A follow-up medwatch will be filed upon its completion.Halyard health 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

Halyard received a single report that referenced two different incidences, which were associated with separate units, involving two different devices.This is the first of two reports.Refer to 2026095-2016-00147 for the second device.It was initially reported that a device was received with an open seal on the left edge of the packaging.Additional information received on 19aug2016 stated that the incident was discovered on (b)(6) 2016, and was found upon opening.Further information received on 19aug2016 stated that another unit was found in addition to the first device.

Manufacturer Narrative

Corrected data: if other, specify field was filled in as "not received by manufacturer" on the initial report.This should have been left blank since the product was received and reported as such on the same initial report.The package was returned for evaluation and during evaluation it was confirmed that the there were openings on the packaging, however products were unused.The opening on the packaging was observed on the pre-sealed areas of the pouches, which are made by the supplier.The pouch is manufactured by a third party and received by halyard.The root cause is attributed to receiving and finished device acceptance.Since the issue was found in a supplier seal, it was verified that the receiving inspection report and seal strength is not required as a critical inspection for this pouch.Corrective actions were implemented at incoming inspection to perform seal strength to the pouch as well as corrective actions to update drawings to include seal strength as a critical point for inspection.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).

• Brand Name: SURGPN,400X2-14,CB SAF,-,OQ,5
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5955822
• MDR Text Key: 55327386
• Report Number: 2026095-2016-00146
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

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
• Device Operator: Other Health Care Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: 0202409740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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