MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET; FILTER, INFUSION LINE

Catalog Number MX448HFB

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

See mfr: 3012307300-2017-01727 and 3012307300-2017-01797 (same patient).

Event Description

It was reported that the filter of a medex¿ ultra¿ small bore extension set was leaking.It was noted that the patient's bed was wet around twelve hours after infusion was started.There was no leakage noted from any of the connections.Upon inspection, the lipid filter was clogged with blood.The wet on the bed look more like total parenteral nutrition (tpn).It appears that the filter was leaking somewhere, causing the tpn and blood to back up.None of the pumps alarmed.No injury was reported.

Manufacturer Narrative

Three used and one unused medex¿ ultra¿ small bore extension sets were returned for investigation.The used samples were contaminated with blood residue on the filter and tubing, and thus were not functionally tested.A visual inspection was performed on all samples and no visible defects were found.The unused sample had a stopcock attached to it that was not part of the reported device.Functional testing on the unused sample was performed and no leakage was observed.The complaint was not confirmed, and no root cause was determined.

• Brand Name: MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING SA DE CV; carretera miguel aleman km21.7; parque industrial monterrey; apodaca, nl CP 66 603; MX CP 66603
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6776949
• MDR Text Key: 82148266
• Report Number: 3012307300-2017-01730
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• 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: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/27/2020
• Device Catalogue Number: MX448HFB
• Device Lot Number: 3374802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TOTAL PARENTERAL NUTRITION