MAUDE Adverse Event Report: BEMIS MFG. CO. OHIO MEDICAL

Model Number AI4080000

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

Our oem customer provided info that one of their customers had a canister implosion during a routine checkout at "400 mm." there was no pt involvement and no injury reported.

Manufacturer Narrative

Probable cause is uv embrittlement of aged product.From info provided by the oem distributor of this product and our shipping records to the oem the lot number involved in this complaint is one of the following: (b)(4); therefore, the product is between (b)(4) old.Since (b)(4) 2007 this product bears a three year expiration date.Since(b)(4) 2011 it has been manufactured with a uv stabilizer and antioxidant package to delay the onset of uv embrittlement.No product is being returned at this time, and no further action is anticipated.

• Brand Name: OHIO MEDICAL
• Manufacturer (Section D): BEMIS MFG. CO.; sheboygan falls WI 53085
• Manufacturer Contact: john cutting ; w2940 old cty pp; sheboygan falls, WI 53085 ; 9204678927
• MDR Report Key: 4458897
• MDR Text Key: 16185588
• Report Number: 2133713-2015-00001
• Device Sequence Number: 1
• Product Code: KDQ
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AI4080000
• Device Catalogue Number: 428010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2015
• 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
• Patient Sequence Number: 1