MAUDE Adverse Event Report: CARDINAL HEALTH MOBERLY PORTA SAMPLE COLD PK 3X8.25; PACK, HOT OR COLD, DISPOSABLE

Model Number	30635-611
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review could not be performed as the lot number was unknown.Since no samples were available, we could not determine a failure mode or definitive root cause.The plant¿s quality system mandates suitable in-process controls to measure seal integrity of representative samples.Forty samples were pulled during production of each of these lots and tested at predetermined locations to best gauge the seal integrity by pull test and functional leak testing.All samples pulled from these lots met the predetermined criteria before they were released.A corrective action will not be initiated at this time since no samples were provided and the information is not sufficient to identify a root cause.We will continue to monitor the complaints for this issue.
Event or Problem Description
Based on information from the customer, on (b)(6)2017 about 2:40 pm, a lab clerk sustained an exposure from the porta sample cold pack.The cold pack was placed in a biohazard bag with specimen during transport, however upon receipt the bag was leaking the ammonium nitrate in the biohazard bag.When she went to open the bag to get the specimen, the ammonium nitrate splashed into her right eye.She immediately rinsed and reported to the emergency center for treatment.

• Brand Name: PORTA SAMPLE COLD PK 3X8.25
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 6776423
• Report Number: 1423537-2017-00117
• Device Sequence Number: 1604752
• Product Code: IMD
• UDI-Device Identifier: 00630140015680
• UDI-Public: 00630140015680
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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
• Operator of Device: No Information
• Device Model Number: 30635-611
• Device Catalogue Number: 30635-611
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 83