MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. BURETTE W/VALVE PP SITES MICRODRP 198CM

Catalog Number 14236

Device Problems Particulates (1451); Insufficient Flow or Under Infusion (2182)

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

Event Date 06/22/2014

Event Type  malfunction  

Event Description

The customer contact reported particulate.The soluset was being used to deliver an unspecified solution, at an unspecified rate.At 0915, the customer contact reported that cefixime 2gm was diluted in 90ml normal saline, for a total volume of 100ml, to be delivered via burette, at an unspecified rate, and the delivery was started.No specific details were provided.It was reported that after one hour, 20ml of solution has been delivered.The customer contact reported that the nurse assessed the patient's iv site and noted slight redness and indicated that the sight was beginning to get tender.The iv site was changed.It was reported that one hour after the insertion, an additional 40ml of solution had been delivered.It was reported that the nurse checked the delivery every 15 minutes to determine the reason why the delivery was so slow.After an unspecified length of time, it was reported that the nurse heard a small splash.At this time, the nurse looked up at the soluset and noted infiltrates/precipitates at the chamber.No specific details were provided.The customer contact reported an unspecified medical intervention was given; however, it was reported there was no delay of critical therapy.There were no reported adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.The catalog number provided is the international list number that was involved in the reported event, which is comparable to the domestic list number.(b)(4).The reporter was contacted and information on reprocessing of the device was requested; however, the information was not obtained.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: BURETTE W/VALVE PP SITES MICRODRP 198CM
• Type of Device: UNK
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora de heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora de heredia ; CS
• Manufacturer Contact: juergen schmider, md, vp. ; 275 n. field dr.; bldg. no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4114767
• MDR Text Key: 4840590
• Report Number: 9615050-2014-05228
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14236
• Device Lot Number: 191235H
• Other Device ID Number: 12728
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1