MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; LIMB HOLDER

Model Number M2028

Device Problem Torn Material (3024)

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

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is currently in progress.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? health professional.Was a medical procedure involved? no.Did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: the initial blame is being cast on our restraint pulling apart and stretching to the point where the patient could extubate themselves and pull out all of their other lines.How was the quality issue was identified? by actual use.How was the product being used? restraining a patient's wrist in the icu.Was it the initial use of the product? no.Was the product modified from the original condition supplied by deroyal? no.Was the product connected to or used in conjunction with other devices or equipment? yes.Please describe connected equipment type, settings, etc.: icu in a progressive bed.Person(s) affected by outcome(s) checked above: patient.Known pre-existing condition(s) of person(s) affected: icu patient, no specifics were given as to their diagnosis.Was the incident reported to the fda? no.Detailed description of outcome(s), including information regarding injury or any additional treatment/ intervention required: the patient pulled all of their lines out and extubated themselves.Everything had to be put back in, however the patients was released yesterday according to the nurse.

Manufacturer Narrative

Investigation findings: according to the picture provided, it has been determined that the problem reported is related to a manufacturing sewing issue.Process records could not be reviewed because no lot number was provided by the customer.Work in process evaluation performed for product on hand at manufacturing facility, does not show any issues.A total of (b)(4) limb holders for the part in reference have been sold from jan/02/15 through jan/23/17 and no complaints due manufacturing issues have been reported for the same period of time.Root cause: sewing error.The bobbin ran out of thread during the process of the work order.Operator did not check previous devices to assure no product with false tacks was completed.Corrections: repairs, reworks, adjustments, reimbursement or replacements.No compensation was requested by the customer.Corrective action: because no lot number was provided to train specific operator for the error made, the current personnel who performs the tacking operation in the line will be informed of the issue.Personnel will be instructed to make sure they check that the devices are not sewn with false tacks when the bobbin runs out of thread and to check previous devices to avoid false tacks.Quality control personnel has been informed of the issue as well, in order to make sure they check that devices from the quality control inspections are not sewn with false tacks.Preventive action: not applicable.Corrective action has been taken due the existing non-conformity from the customer.No further information is available at this time.We will provide follow up report if additional information becomes available.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: DEROYAL
• Type of Device: LIMB HOLDER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a; villa canales; villa canales, guatemala 01065 ; GT 01065
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a; villa canales; villa canales, guatemala 01065 ; GT 01065
• Manufacturer Contact: elizabeth reed ; 200 debusk ln; powell 37849 ; 8653621256
• MDR Report Key: 6254401
• MDR Text Key: 64929542
• Report Number: 3010452421-2017-00001
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M2028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other