MAUDE Adverse Event Report: GEO-MED LLC MINOR ABDOMINAL TRAY; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 89-6137

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Root cause: the defective device within the custom pack was an or safety towel ((b)(4)), which is supplied to deroyal by (b)(4).A sample was not returned for evaluation, and therefore, the source or type of contamination cannot be identified.In response to a supplier corrective action request from deroyal, (b)(4) stated it performed verification testing on retention samples and was unable to find the "spots" described in the complaint report.A defective sample is required to identify the source of the "spot" and the process during which it could have been generated.Corrective action and/or systemic correction action taken: the supplier of the towel, (b)(4), has determined a corrective action is not necessary at this time.Investigation summary an internal complaint ((b)(4)) was received indicating that a minor abdominal pack ((b)(4), lot number 39072706) contained a towel with "dark spots." the towel was identified as an or safety towel ((b)(4)), which is supplied by (b)(4).The qc complaint specialist reviewed the 2013-2015 supplier corrective action request (scar) and supplier notification letter (snl) logs for similar complaints.However, no similar complaints were identified for the raw material and issue reported.Due to the nature of the complaint, a scar was issued to (b)(4) and a response received 10/26/2015.Due to the reporting customer not providing samples for evaluation, neither (b)(4) nor deroyal was able to identify the source of the reported "dark spots." the qc complaint specialist reviewed the work order for discrepancies that would have contributed to the reported issue, but no such discrepancies were identified.Deroyal will continue to monitor trends for this failure and will recognize in the future if it transitions into a recurring issue.Preventive action: in its scar response, (b)(4) stated a preventive action is not necessary at this time.The investigation is complete.This report will be updated if new and critical information is received.Device not returned to manufacturer.

Event Description

Upon opening a package for a minor abdominal tray distributed by (b)(4), lot 39073706, expiration date 06/20/2018, staff noted that a sterile towel had several dark colored spots that were approximately 1 mm in size clearly visible on the towel.This is a custom package made for (b)(6).The pack was replaced and no harm to the patient or delay in patient care was experienced.

• Brand Name: MINOR ABDOMINAL TRAY
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): GEO-MED LLC; 478 east altamonte drive; suite 108; altamonte springs FL 32701
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5234637
• MDR Text Key: 31573359
• Report Number: 3005011024-2015-00012
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: 89-6137
• Device Lot Number: 39072706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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