MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. PICC TRAY; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Catalog Number 89-6417

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause: the placement of the instruments within the tray allowed them to shift during shipping.Corrective action: the tray engineering department built a sample of this tray and rearranged the instruments, placing them in separate packaging from the other components in the tray.This placement will provide an extra barrier between the instruments and the outer packaging of the tray.An engineering change order ((b)(4)) was initiated and implemented to make this change effective.Investigation summary an internal complaint ((b)(4)) was received indicating that while unpacking a picc tray (finished good (b)(4), lot number 42286537), a pair of scissors came through the pack and cut an end user's hand.The device master record was reviewed and no discrepancies were identified that would contribute to this issue.No discrepancies were found.A sample was unavailable for evaluation.Therefore, the exact placement of the scissors within the pack could not be determined.No inventory was available for review at the distribution center.Preventive action: due to this being an isolated incident, a preventive action is not required.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

He was unpacking a case of picc packs (finished good (b)(4), lot number 42286537) and a pair of scissors came through the pack and cut his hand.Since the scissors came through the pack wrapping, he will need one replacement pack.Once the pack was compromised, he opened the pack to see how the scissors were protected and found them upright.

• Brand Name: PICC TRAY
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• 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: 5906866
• MDR Text Key: 54153570
• Report Number: 3005011024-2016-00024
• Device Sequence Number: 1
• Product Code: PEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-6417
• Device Lot Number: 42286537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2016
• 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: Initial
• Patient Sequence Number: 1