MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND 90 ML PREFILLED PJ; 90 ML PREFILLED PJS

Model Number 3800780

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)

Patient Problems Respiratory Distress (2045); Chemical Exposure (2570)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following the investigation.

Event Description

On (b)(6) 2018, product was received by customer materials management department and arrived leaking and damaged.Outer case packaging was reported to be dry while the inner case packaging was reported to be wet from leakage.Customer employee who opened the outer case packaging was exposed to formalin fumes and sought medical attention for respiratory problems.No follow up medical attention was required, employee was released the same day.Product was disposed by the carrier.

Manufacturer Narrative

Investigation actions and timeline: a supplier corrective action (scar 38) was issued to the supplier of the jars used in the manufacture of the impacted product (part number 3800780).This scar was issued based on preliminary findings that inadequate sealing of the jar packaging was contributing to product leaking during transit.Due to the inability of the supplier to resolve the issue with their current jar design, a new jar supplier was qualified under capa 2018-006, and jars from the original supplier were discontinued on (b)(6) 2018.Root cause: jar packaging from the original supplier was not adequately sealing to prevent leaking during transit.Corrective action: capa 2018-006 documents the qualification of a new jar supplier for part number 3800780.Based on a review of complaints since the implementation of the new jars from this supplier and discontinuing the original supplier on 12/03/2018, zero reported complaints have been received for leaking of part number 3800780, indicating the effectiveness of the corrective actions taken.

Event Description

On (b)(6), 2018, product was received by customer materials management department and arrived leaking and damaged.Outer case packaging was reported to be dry while the inner case packaging was reported to be wet from leakage.Customer employee who opened the outer case packaging was exposed to formalin fumes and sought medical attention for respiratory problems.No follow up medical attention was required, employee was released the same day.Product was disposed of by the carrier.

• Brand Name: 90 ML PREFILLED PJ
• Type of Device: 90 ML PREFILLED PJS
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND; 5205 rte 12; richmond IL 60071
• MDR Report Key: 7526550
• MDR Text Key: 108667882
• Report Number: 1419341-2018-00001
• Device Sequence Number: 1
• Product Code: IFP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 3800780
• Device Lot Number: 022720
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other