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

Model Number 30635-611

Device Problem Material Rupture (1546)

Patient Problem Chemical Exposure (2570)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review could not be completed as the lot number was not provided.At the time of this investigation no samples were available, therefore, 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-eight 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.This product is to be used in the upright position.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.The manufacturing site will continue to monitor the incoming complaints for burst against this product.

Event Description

Based on information received from the customer, on (b)(6) 2018 a phlebotomist sustained a splash to the eyes after a porta sample cold pack ruptured upon activation.The phlebotomist flushed his eyes and reported to employee health.

• Brand Name: PORTA SAMPLE COLD PK 3X8.25
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7331731
• MDR Text Key: 102141747
• Report Number: 1423537-2018-00167
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 50630140015685
• UDI-Public: 50630140015685
• 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
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 30635-611
• Device Catalogue Number: 30635-611
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Weight: 91