MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number DI-50

Device Problems Break (1069); Detachment Of Device Component (1104); Out-Of-Box Failure (2311)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch report #: mw5066816.The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that a level 1 disposable normothermic iv administration set double spike was detached from the drip chamber and the plastic was broken.The issue was observed when the product was opened initially.It was noted that there was no damage to the packaging prior to opening.It was initially reported that the product did not reach the patient, but then it was reported that a serious injury occurred.It was unclear what the impact to the patient was.

Manufacturer Narrative

One photo was returned for evaluation.Photographic inspection found that the drip chamber was separated from the 3-day y connector and that the inlet of the single port cap was broken.One device was returned for evaluation in used condition and without its original packaging.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manuafacturing process was performed on a similar part.A sample of 32 devices was taken for visual inspection and found no discrepancies.Functional testing involved simulated use testing with 4 device samples with excess solvent and was found to be bent and not broken.Functional testing involved a pull test with 4 device samples and found the samples completely split as the complaint device did.Based on the evidence, the root cause was unable to be determined.

• Brand Name: LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS
• Type of Device: DEVICE, WARMING. BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6312295
• MDR Text Key: 66827056
• Report Number: 3012307300-2017-00488
• Device Sequence Number: 1
• Product Code: KZL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK860023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: DI-50
• Device Lot Number: 3189735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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
• Patient Outcome(s): Hospitalization; Other; Disability