MAUDE Adverse Event Report: NETWORK MEDICAL PRODCUCTS (USA) INC EYETEC; CELLULOSE SPEAR

Model Number 40-410-USA

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

Product inspection: product was returned to nmp-usa by distributor ((b)(4) full box, (b)(4) partial w/6 pouches).(b)(4) pouches were opened and spears examined dry for frayed edges.The number of spears per pouch with obvious edge fraying was quantified.Photos were taken of the worst example in each pouch.Spears were then submerged in water and rubbed vigorously back and forth several times over a hard surface, to exaggerate actual use.No spears fell apart.Spears from (b)(4) additional lots spanning manufacturing dates from april, 2014 to december, 2015 were examined in the same fashion.No significant differences were noted in quantity or degree of fraying.The subject lot was not unusually frayed as compared with other cellulose lots.Batch records of the suspect lot were checked: final inspection form for the suspect lot, dated november 21, 2015, showed no anomalies.Inspector/packer trained on the inspection procedure on april 23, 2015.Sterilisation records checked by production manager on october 30, 2015.Dose exposure confirmed, sterilisation lot number traced to nmp product ref and lot #s.Sterilisation coc signed october 30, 2015.Shipment to steriliser packed by production manager on september 25, 2015, (b)(4) traced to (b)(4).(b)(4) spears, production dates prior to and including september 25, 2015, were packed by trained operators: operator 1 (trained jun.14,2014), operator 2 (august 21,2014), operator 3 (july 22, 2015), operator 4 (september 10, 2015).(b)(4) spears, production dates prior to and including september 25, 2015, cut by trained operators: operator 1 (june 30, 2014), operator 2 (september 17, 2015).Sprig shipments (b)(4) received and inspected by production supervisor (trained september 29, 2015) and found to be acceptable and unremarkable.Raw material lot 110194, shipments of which were received at nmp-usa july 24, august 12 and september 22, 2015.All lots inspected by supervisor production supervisor (trained june 30, 2015) and found to be acceptable.A level of particulate is common to all spears industry wide.No deficiencies in product quality could be identified.Conclusion - device was inappropriately used (surgical site insufficiently irrigated).No further action proposed.Device not returned.

Event Description

Distributor reported end user feedback from customer monticello surgery via email that a patient had to have additional surgery to remove a retained piece of cellulose foam in the patient's eye.No information was given about the type of procedure conducted with the cellulose spear.

• Brand Name: EYETEC
• Type of Device: CELLULOSE SPEAR
• Manufacturer (Section D): NETWORK MEDICAL PRODCUCTS (USA) INC; 183 prov-new london tpke,; suite w9; north stonington CT 06359 1721
• Manufacturer (Section G): NETWORK MEDICAL PRODUCTS (USA) INC.; 183 prov-new london tpke; suite 9; north stonington CT 06359 1721
• Manufacturer Contact: alison march ; 183 prov-new london tpke; suite w9; north stonington, CT 06359-1721 ; 8604952055
• MDR Report Key: 5867907
• MDR Text Key: 51936817
• Report Number: 3011093388-2016-00001
• Device Sequence Number: 1
• Product Code: HOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-410-USA
• Device Catalogue Number: 40-410-USA
• Device Lot Number: 15EST0128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• 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): Required Intervention