MAUDE Adverse Event Report: BEMIS MANUFACTURING BEMIS CANISTER; VACUUM CANISTER

Model Number B1605

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2015

Event Type  malfunction  

Manufacturer Narrative

A complaint was received related to a bemis canister, product code (b)(4).The canister is a single use, disposable vacuum canister used with our mammotome vacuum assisted biopsy system to facilitate vacuum, managing fluids, and enabling tissue acquisition during a breast biopsy procedure.Although the canister is not manufactured by devicor, nor does devicor hold the regulatory pathway, it is an integral part of our system, and the failure would not be observed without its use with our system.This event was forwarded to the manufacturer for review and mdr assessment.However, after further clinical review of this failure mode with devicor's medical department, this event was reassessed and determined to be mdr reportable as a malfunction of the system.Pursuant to 21 cfr 803 as a result of potential for serious injury should a malfunction recur, we are submitting this medwatch report.Device not returned for analysis.

Event Description

It was reported by the sales rep that during an ultrasound breast biopsy demo procedure the canisters exploded.Both times the machine has been used in its lifetime.This is a new unit.The demo procedure was stopped and not completed.The canisters shattered into several pieces.The lids did not crack.There were no fluids in the canisters.There was no patient consequence.

• Brand Name: BEMIS CANISTER
• Type of Device: VACUUM CANISTER
• Manufacturer (Section D): BEMIS MANUFACTURING; w2940 old city pp; sheboygan WI 53083
• Manufacturer (Section G): BEMIS MANUFACTURING; w2940 old city pp; sheboygan WI 53083
• Manufacturer Contact: lorraine thomas ; w2940 old city pp; sheboygan, WI 53083 ; 9204675457
• MDR Report Key: 5103413
• MDR Text Key: 26720407
• Report Number: 3008492462-2015-00061
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1605
• Device Catalogue Number: B1605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1