MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURFLO IV CATHETER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ulcer (2274); No Code Available (3191)

Event Date 12/06/2015

Event Type  malfunction  

Manufacturer Narrative

Note: although this report is related to a product that is labeled for use in the veterinary market, the product is identical to product that is labeled for human use.Therefore, this report is being submitted as a precautionary measure.(b)(4).The actual device has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date this report was sent.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.Device not returned to manufacturer.

Event Description

The user facility reported experiencing issues with non-healing wound on an animal patient after using a terumo sr product.The doctor reported he had a (b)(6) animal patient infected with the parvo virus, who has been hospitalized since (b)(6) 2015 free of charge; (2) the animal patient was initially treated with 2 antibiotics and the wound looks much better now.Follow up communication with the user facility reported: the animal patient was presented at the facility with parvo virus; the doctor reported he does not remember who placed the catheter or what size the catheter was; it was reported they typically use 22g or 20g, sometimes 24g; the doctor reported he believed the puppy may have chewed the catheter (ate, came loose, or broke), and extravasation was noted at the time; the doctor reported he was not overly concerned, as edema is common; the doctor placed another catheter in the other forearm without issue; the animal patient went home and returned to the facility a few days later with a decubitus ulcer on (b)(6) 2015; the wound was the size of a quarter and squirted pockets of clear fluid across the room (area had thickened skin, dorsal & proximal to catheter placement); the animal patient is doing much better and the wound has healed, but not completely, without any signs of infection; it was reported the doctor was going to take ap & lateral x-rays on the animal patient's forelimb.Additional information was reported on 1/15/16: the doctor reported he did not observe any catheter pieces or fragments.The reported complaint is the same complaint reported in mdr no.1118880-2016-00023.Due to the unknown product code and lot number it could not be determined which factory manufactured the unknown surflo.An investigation is being completed on behalf of both (b)(4).

Manufacturer Narrative

This report is being submitted as follow up no.1 for mfg.Report no.3003902955-2016-00002 to provide the investigation evaluation.The actual device was not returned to the manufacturer for evaluation.The lot number and product code are unknown for this complaint.Since product code and lot number are unknown, our investigation is limited.Records confirmed needle penetration testing on products meet manufacturer specification.All lots produced are tested for endotoxin thru limulus amebocyte lysate test to check presence of bacterial endotoxin on our finished products and have met specification for endotoxin limit for medical devices.In addition, qc performs monthly monitoring of the physical and chemical properties of the sterile products per gauge through the physicochemical test.Test items include test for acidity/alkalinity and traces of metals such as cadmium, lead, iron, zinc and tin.Our products comply with iso 10993-1; biological evaluation for medical devices.Also, all finished product are sterilized prior to shipment.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow up no.1 for mfg.Report no.3003902955-2016-00002 to provide the investigation evaluation.

• Brand Name: SURFLO IV CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna, reg. no. 3003902955 ; RP
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset 08873 ; 8002837866
• MDR Report Key: 5427314
• MDR Text Key: 37987116
• Report Number: 3003902955-2016-00002
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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