MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,600X1-7D,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB6007

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The device history record for the lot number, 0202361760, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The pump was received full.The pinch clamp was opened the pump infused at all selectable flowrates for both safs.The bladder lacked the normal rigidity typically associated with a full pump.A scissor was used to cut open the dust cover and a break was observed in the inner latex membrane and kraton layer.The tubing was cut below the blue connector to drain the pump.A scissor was then used to cut and remove the outer latex membrane.Signs of stress were observed in the corners of the inner latex and kraton membrane break.The investigation summary concludes that a break was present on the inner latex membrane and kraton layer.The pump was received full and infused at all selectable flow rates for both saf's.After opening the dust cover with a scissor the breaks were noticed.The pump was drained and the dust cover and outer latex membrane fully removed to reveal the break.Signs of stress were seen on the corners of the break for the inner latex and kraton membranes.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

Fill volume: 750 ml, flow rate: unknown.An initial complaint was received on 07-jun-2016 stating a pharmacist reported one pump made a popping sound from within the bolus and immediately had a technician stop filling the device.The pump did not appear to be leaking.The pump was not administered to a patient, there was no patient contact.Additional information received 08-jun-2016 stated the pharmacist explained the sound worried her because she assumed with the pop, a leak would occur and did not want to risk an adverse effect.The pump itself appeared to be full and the container it was in did not appear to have any visible moisture.Additional information received 14-jun-2016 stated the investigation for the returned sample device noted a break was present on the inner latex membrane and kraton layer.No further information to be provided.

Manufacturer Narrative

"additional information received 14-jun-2016" corrected to "additional information received 13-jun-2016".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,600X1-7D,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: 5796058
• MDR Text Key: 50427103
• Report Number: 2026095-2016-00097
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

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: 07/31/2018
• Device Model Number: CB6007
• Device Catalogue Number: 101347703
• Device Lot Number: 0202361760
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1