MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,CB006,CBCMBO,-,OQ,5; ELASTOMERIC - COMBO

Model Number CB006

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # unknown.Method: the actual device was not returned.A lot number was not provided and review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to (b)(4) for evaluation therefore, we are unable to determine the cause for the reported event.(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.Device not returned.

Event Description

Fill volume: unknown; flow rate: unknown; procedure: pectus excavatum repair surgery; cathplace: tunneled across rib posterior-lateral to the wound.A report was received stating the physician reported that an increase in infection rate was noted at the user facility.The physician orally reported an approximate 27% infection rate in patients receiving the onq device for postoperative pain.The normal rate for this procedures was approximately 4%.The catheter was placed during surgery, it was capped and the pump was initiated about 2-days later.The infection was in the surgical wound site.The catheter was not placed in the wound rather it was tunneled across rib posterior-lateral to the wound, approximately 5-inches away.Additional information has been requested.No additional information was provided.

• Brand Name: SURGPN,CB006,CBCMBO,-,OQ,5
• Type of Device: ELASTOMERIC - COMBO
• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5686339
• MDR Text Key: 46164463
• Report Number: 2026095-2016-00054
• 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
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: CB006
• Device Catalogue Number: 101347401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other