MAUDE Adverse Event Report: BEMIS MANUFACTURING COMPANY OHIO MEDICAL; BOTTLE, COLLECTION, VACUUM

Model Number AI4080000

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2018

Event Type  malfunction  

Event Description

Oem informed us that a hospital experienced a canister cover implosion during a routine equipment checkout.There was no patient involvement, and no injury reported.

Manufacturer Narrative

Returned lid was photographed and subject to ftir analysis.Ftir indicated a high degree of oxidation consistent with uv embrittlement.Canister was a component of a portable pump, exposed to lighting for an extended period.Product was past its expiration date.Immediate actions: requested return of lid so that lab analysis can be performed.Investigation results/response to customer: complaint received from (b)(6) states the incident occurred on (b)(6) 2013.The product has an expiration date of 06/2013.Preliminary probable cause would appear to be embrittlement of the ageing cover due to excessive uv exposure.In our experience, most portable pump manufacturers include a warning to replace suction canisters on a routine annual basis as part of the facility's pm process to specifically address this type of failure.Once the part is returned, we can perform analysis on the plastic and confirm (possibly) this is the cause.Conclusion: returned fractured cover was received on 1/21/2014 and was forwarded to the lab for ftir analysis.On (b)(4) 2014 the lab reported back with results indicative of a high degree of oxidation typical of high density polyethylene exposed to uv for an extended period.This supports the initial probable cause.Lab analysis is attached to this report.

• Brand Name: OHIO MEDICAL
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): BEMIS MANUFACTURING COMPANY; sheboygan falls WI 53085
• Manufacturer Contact: john cutting ; w2940 old cty pp; sheboygan falls, WI 53085 ; 9204678927
• MDR Report Key: 3818983
• MDR Text Key: 4394457
• Report Number: 2133713-2014-00004
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2013
• Device Model Number: AI4080000
• Date Returned to Manufacturer: 01/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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