MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Catalog Number MX4705

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.

Event Description

It was reported that a medex¿ clear-cuff pressure infusor had burrs and was leaking.No injury was reported.See mfr: 3012307300-2017-01012, 3012307300-2017-01077, 3012307300-2017-01078, 3012307300-2017-01079, 3012307300-2017-01080, 3012307300-2017-01081, 3012307300-2017-01083, 3012307300-2017-01084, 3012307300-2017-01085, and 3012307300-2017-01086, and 3012307300-2017-01087.

Manufacturer Narrative

Twelve devices were received for evaluation.Visual inspection of the devices discovered small burrs on the side of the bags.Functional testing involved a leak test and all twelve devices were inflated and left overnight; it was observed that the devices held the same amount of air that the devices were inflated with, and therefore the leaking was not observed.A review of the manufacturing process identified that dies that were used to cut the device were dull and needed adjustment, which was corrected prior to the production of the reported lot.Based on the evidence, the complaint was unable to be confirmed.The returned device functioned as specified.There was no evidence to indicate that there was an intrinsic defect in the product.

• Brand Name: MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6569159
• MDR Text Key: 75322592
• Report Number: 3012307300-2017-01082
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

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: No Information
• Device Catalogue Number: MX4705
• Device Lot Number: 3317569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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